Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02554318
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2015-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D013851', 'term': 'Thinness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012293', 'term': 'Rifampin'}, {'id': 'D007538', 'term': 'Isoniazid'}, {'id': 'D011718', 'term': 'Pyrazinamide'}, {'id': 'D004977', 'term': 'Ethambutol'}, {'id': 'D045730', 'term': 'Soy Foods'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D005029', 'term': 'Ethylenediamines'}, {'id': 'D003959', 'term': 'Diamines'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000074421', 'term': 'Fermented Foods'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nehesa@gmail.com', 'phone': '+6287751644522', 'title': 'Dr. Budhi Setiawan', 'organization': 'Medical Faculty Wijaya Kusuma Surabaya'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It needs more participants and not all patients were tested for HIV since it was not suitable for the local culture. High temperature which is involved in the cooking process could change the chemical properties of tempeh. Since physical activity consists of complex aspects, a combination of several tools can be used in a study to give a comprehensive view of interpretation.'}}, 'adverseEventsModule': {'timeFrame': 'The intervention period was 2 months for each participant who is eligible for the study. All participants were assessed at month zero (baseline) and month two (end line). The recruitment method was not a one-time event but a referral from physicians. Since eligible participants were not always available every day at the clinics thus the adverse data collection period for all participants was 1 year and 3 months.', 'description': 'The definition of adverse event and/or serious adverse event, used to collect adverse event information, are the same from the clinicaltrials.gov definitions. Observation for adverse event was done three times a week since the food should be delivered regularly and regular notes taken on a log book.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 1, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 0, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Vomiting'}], 'frequencyThreshold': '0.013'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'categories': [{'measurements': [{'value': '2.80', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months', 'description': 'Change of body weight of the participants over the two months intervention period as measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. A higher value score in change means a better outcome on nutritional status for the patients after the study.', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were assessed their body weight (kg) using an electronic weight scale before and after the study to determine its change.'}, {'type': 'SECONDARY', 'title': 'Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'categories': [{'measurements': [{'value': '3.90', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '4.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months', 'description': 'The change of hand-grip strength of the participants over the two months intervention period was measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. The higher scores reflected the better physical function outcomes of the patients.', 'unitOfMeasure': 'Kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were measured from two-times points, before and after the study in order to analyze their change after 2 months of intervention. Higher values reflected better physical function results.'}, {'type': 'SECONDARY', 'title': 'Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'categories': [{'measurements': [{'value': '49.67', 'spread': '58.49', 'groupId': 'OG000'}, {'value': '25.75', 'spread': '56.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months', 'description': 'The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes.', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants were analyzed before and after the study to measure the change in the distance. Only 64 participants from the intervention group and 63 participants from the control group contributed to data collection.'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index (BMI) From Baseline at 2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 2 months', 'description': 'The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients.', 'unitOfMeasure': 'Kg/m²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were assessed before and after the study using a standard formula to determine the change of the body mass index (BMI).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'title': '2nd week', 'categories': [{'measurements': [{'value': '1980.10', 'spread': '437.79', 'groupId': 'OG000'}, {'value': '1844.64', 'spread': '592.13', 'groupId': 'OG001'}]}]}, {'title': '6th week', 'categories': [{'measurements': [{'value': '2227.98', 'spread': '463.72', 'groupId': 'OG000'}, {'value': '2059.27', 'spread': '550.52', 'groupId': 'OG001'}]}]}, {'title': 'Average', 'categories': [{'measurements': [{'value': '2113.16', 'spread': '429.41', 'groupId': 'OG000'}, {'value': '1972.12', 'spread': '530.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.', 'description': 'The average calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country-specific food database for Indonesia.', 'unitOfMeasure': 'Kcal/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants were assessed their calorie intake, only 61 participants in the control arm and all participants from intervention contributed to the data collection.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Protein Intake on 24-hour Dietary Recall Method.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'OG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'classes': [{'title': '2nd week', 'categories': [{'measurements': [{'value': '77.34', 'spread': '27.98', 'groupId': 'OG000'}, {'value': '69.49', 'spread': '22.81', 'groupId': 'OG001'}]}]}, {'title': '6th week', 'categories': [{'measurements': [{'value': '77.70', 'spread': '26.72', 'groupId': 'OG000'}, {'value': '73.35', 'spread': '24.37', 'groupId': 'OG001'}]}]}, {'title': 'Average', 'categories': [{'measurements': [{'value': '77.52', 'spread': '26.63', 'groupId': 'OG000'}, {'value': '71.42', 'spread': '21.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.', 'description': 'The average protein intake (in Gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia.', 'unitOfMeasure': 'Gram/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all participants were assessed before and after the study, only 61 participants from the control group contributed to the data collection of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'FG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Between November 2013 and February 2015, patients who attended the lung clinics in Surabaya for newly diagnosed pulmonary TB were screened for study enrollment.', 'preAssignmentDetails': 'After the enrollment of the study, several participants withdrew their assignment due to several reasons such as underlying disease, heavy smoker, they did not stay in the city, plan to move to other city, and dislike the food.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol\n\nFermented soybean'}, {'id': 'BG001', 'title': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nRifampicin\n\nIsoniazid\n\nPyrazinamide\n\nEthambutol'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were newly diagnosed adult male and female pulmonary TB active patients aged between 18 and 55 years.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'The number of Baseline Participants was assigned to the arm groups based on the inclusion and exclusion criteria. Some of them have rejected and withdrawn for some reasons such as objection and underlying diseases.'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.11', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '34.45', 'spread': '10.35', 'groupId': 'BG001'}, {'value': '32.77', 'spread': '10.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Javanese', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Madurese', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Indonesia', 'categories': [{'title': 'Surabaya, East Java', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '18.41', 'spread': '3.10', 'groupId': 'BG000'}, {'value': '18.57', 'spread': '3.26', 'groupId': 'BG001'}, {'value': '18.49', 'spread': '3.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Elementary School', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Middle School', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'High school', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Bachelor', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Income (million rupiahs)', 'classes': [{'categories': [{'title': 'Less than one', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Between one to three', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'More than three', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Occupation', 'classes': [{'categories': [{'title': 'Unemployed', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Part timer', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Private', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sputum Smear', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Analysis Population of the participants was assessed by age, gender, education, income, occupation, ethnicity, sputum smear examination result, and Body Mass Index.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2015-09-14', 'resultsFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-23', 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Caloric Intake on 24-hour Dietary Recall Method at the 2nd and 6th.', 'timeFrame': 'In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.', 'description': 'The average calorie intake (in kcal/day) was assessed by the 24-hour dietary recall questionnaire and calculated by NutriSurvey software version 2005, with the country-specific food database for Indonesia.'}, {'measure': 'Protein Intake on 24-hour Dietary Recall Method.', 'timeFrame': 'In the course of the 8 week intervention, two interviews were conducted; at the 2nd and 6th week.', 'description': 'The average protein intake (in Gram/day) was assessed by the 24-hour dietary recall questionnaire and calculated using NutriSurvey software version 2005, with the country specific food database for Indonesia.'}], 'primaryOutcomes': [{'measure': 'Change in Bodyweight on a Digital Weight Scale From Baseline at 2 Months', 'timeFrame': 'Baseline, 2 months', 'description': 'Change of body weight of the participants over the two months intervention period as measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. A higher value score in change means a better outcome on nutritional status for the patients after the study.'}], 'secondaryOutcomes': [{'measure': 'Change in Hand-grip Strength on a Digital Dynamometer Scale From Baseline at 2 Months', 'timeFrame': 'Baseline, 2 months', 'description': 'The change of hand-grip strength of the participants over the two months intervention period was measured on a kilograms scale. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Positive numbers represent increases and negative numbers represent decreases. The higher scores reflected the better physical function outcomes of the patients.'}, {'measure': 'Change in Distance on 6-minute Walk Test (6MWT) From Baseline at 2 Months', 'timeFrame': 'Baseline, 2 months', 'description': 'The change distance in meters scale as assessed by 6MWT according to American Thoracic Society (ATS) 2002 guidelines. The 6MWT was carried out on a track along the 30-meter corridor marked by two colored cones placed at both ends of the track alignment. The participants were asked using the standard instruction to walk at their self-selected pace back and forth between the cones as far as they could for 6 minutes. The distance taken by each participant was measured and then recorded. Instructions were given to every patient by reading a guideline with the same intonations to every patient before performing the test. The result of the 6MWT was expressed in meters. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected better physical function outcomes.'}, {'measure': 'Change in Body Mass Index (BMI) From Baseline at 2 Months', 'timeFrame': 'Baseline, 2 months', 'description': 'The change in BMI was assessed by a digital weight scale and height scale (kg/m²). The formula for BMI is weight in kilograms divided by height in meters squared. The change was calculated from two-time points as the value at the later time point minus the value at the earlier time point. Higher scores reflected the better nutritional status results of the patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tempeh', 'Body weight', 'Handgrip strength', '6MWT', 'Supplementation', 'Wasting'], 'conditions': ['Pulmonary Tuberculosis', 'Body Weight Changes', 'Motor Activity']}, 'referencesModule': {'references': [{'pmid': '15277171', 'type': 'BACKGROUND', 'citation': 'Paton NI, Chua YK, Earnest A, Chee CB. Randomized controlled trial of nutritional supplementation in patients with newly diagnosed tuberculosis and wasting. Am J Clin Nutr. 2004 Aug;80(2):460-5. doi: 10.1093/ajcn/80.2.460.'}, {'pmid': '19858174', 'type': 'BACKGROUND', 'citation': 'Martins N, Morris P, Kelly PM. Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste. BMJ. 2009 Oct 26;339:b4248. doi: 10.1136/bmj.b4248.'}, {'pmid': '21221502', 'type': 'BACKGROUND', 'citation': 'Jahnavi G, Sudha CH. Randomised controlled trial of food supplements in patients with newly diagnosed tuberculosis and wasting. Singapore Med J. 2010 Dec;51(12):957-62.'}, {'pmid': '21729372', 'type': 'BACKGROUND', 'citation': 'PrayGod G, Range N, Faurholt-Jepsen D, Jeremiah K, Faurholt-Jepsen M, Aabye MG, Jensen L, Jensen AV, Grewal HM, Magnussen P, Changalucha J, Andersen AB, Friis H. The effect of energy-protein supplementation on weight, body composition and handgrip strength among pulmonary tuberculosis HIV-co-infected patients: randomised controlled trial in Mwanza, Tanzania. Br J Nutr. 2012 Jan;107(2):263-71. doi: 10.1017/S0007114511002832. Epub 2011 Jul 6.'}]}, 'descriptionModule': {'briefSummary': 'Tuberculosis (TB) patients often have a lower body mass index (BMI) and experience wasting. Wasting reduces lean body mass and may cause physical function impairment. This study aimed to determine the efficacy of fermented soybeans (tempeh) as a food supplement on body weight and physical function changes among active pulmonary tuberculosis patients with standard therapy.', 'detailedDescription': 'This study was carried out at the outpatient department building, lung hospital Surabaya, Indonesia. As a national health referral system in TB program, the hospital was related to four local sub district health centers that were involved in the recruitment of participants in the study.\n\nPatients with newly diagnosed pulmonary tuberculosis were randomly assigned into two groups, namely intervention group, which consisted of 65 participants and control group which had 64 participants. Randomization was carried out using sealed, unmarked opaque envelopes that are allocated to participants in this study. A minimum sample size of per group (n=64) was determined by Windows version G\\*Power 3.1.5 software to identify a mean difference in body weight change of ≥1.1 kg between intervention and control groups.\n\nThe intervention group obtained the standard therapy of TB and an additional 166.5 grams of boiled tempeh daily for two months. The control group obtained only standard TB therapy. Patients in the intervention group were instructed to divide one cake tempeh into three pieces and eat them three times in a day. Consumption frequencies of supplements were recorded in a logbook by an enumerator during random visits once a week. One of the patient family members was asked to help to supervise compliance.\n\nThe participants were assessed before and after the intervention period for both groups. Body weight of the participants was evaluated by measuring the change in body weight. The change of physical function was assessed by handgrip strength using a digital dynamometer and 6-minute walk test (6MWT). Protein and caloric intakes were estimated twice, measured during the first and second months using 24-hour dietary recall method during the intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed adult male and female TB active patients\n* Having clinical evidences of active TB symptoms\n* Positive or negative sputum smears\n* Having positive chest X-ray that compatible with a diagnosis of tuberculosis\n* No history of previous anti tuberculosis treatment\n* Give a written informed consent and basic contact data\n\nExclusion Criteria:\n\n* Heavy smoker (\\> 20 cigarettes per day)\n* Pregnancy and lactation\n* Extra pulmonary TB\n* Known allergy to soybean\n* Having clinical evidences of any underlying disease'}, 'identificationModule': {'nctId': 'NCT02554318', 'acronym': 'FSS', 'briefTitle': 'Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'The Effect of Fermented Soybean Supplementation on the Body Weight and Physical Function of Tuberculosis Patients With Standard Therapy in Indonesia', 'orgStudyIdInfo': {'id': 'DGHE 626/E4.4/K/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets\n\nand 166.5 grams cooked fermented soybean (tempeh) daily for two months', 'interventionNames': ['Drug: Rifampicin', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol', 'Dietary Supplement: Fermented soybean']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'TB standard therapy with fixed dose combination :\n\nonce per day by mouth for 2 months Fixed dose combination = RHZE (150mg/75mg/400mg/275mg) R=rifampicin, H=isoniazid, Z=pyrazinamide, E=ethambutol,\n\nPatients with body weight: 30 - 37 kg = 2 tablets, 38 - 54 kg = 3 tablets, 55 - 70 kg = 4 tablets, and ≥71 kg = 5 tablets', 'interventionNames': ['Drug: Rifampicin', 'Drug: Isoniazid', 'Drug: Pyrazinamide', 'Drug: Ethambutol']}], 'interventions': [{'name': 'Rifampicin', 'type': 'DRUG', 'otherNames': ['Rifampin', 'Rifadin'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Isoniazid', 'type': 'DRUG', 'otherNames': ['Hydra', 'Isovit'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Pyrazinamide', 'type': 'DRUG', 'otherNames': ['Actizid', 'Cavizide'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Ethambutol', 'type': 'DRUG', 'otherNames': ['Myambutol', 'Servambutol'], 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Fermented soybean', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Tempeh'], 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael B Krawinkel, Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Giessen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indonesian Directorate General of Higher Education', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr, M.Kes', 'investigatorFullName': 'Budhi Setiawan', 'investigatorAffiliation': 'University of Giessen'}}}}