Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-03-06 @ 6:19 PM
Study NCT ID:
NCT03161106
Status:
WITHDRAWN
Last Update Posted:
2018-12-11
First Post:
2017-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}, {'id': 'D007792', 'term': 'Lactulose'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'due lack of funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-08', 'studyFirstSubmitDate': '2017-05-08', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients develop hepatic encephalopathy in both groups', 'timeFrame': '6 Months'}], 'secondaryOutcomes': [{'measure': 'Improvement in health related quality of life over 6 months', 'timeFrame': '6 Months', 'description': 'Improvement will be defined on the basis of HRQOL (Health Related Quality of Life Index).'}, {'measure': 'Improvement in anthropometry parameters (mid arm circumference, triceps skin fold thickness, hand grip), skeletal muscle mass, body fat mass, percent body fat,BMI over 6 months', 'timeFrame': '6 Months', 'description': 'Improvement will be measured by dexa scan , C T scan and by measuring mid arm circumference, triceps skin fold thickness, hand grip'}, {'measure': 'Time taken for first breakthrough episode of overt hepatic encephalopathy', 'timeFrame': '6 Months'}, {'measure': 'Time to first overt hepatic encephalopathy-related hospital admission', 'timeFrame': '6 Months'}, {'measure': 'Mortality over 6 months', 'timeFrame': '6 Months'}, {'measure': 'Changes in serum cytokines (IL-1,6,10,18,TNF,Endotoxins,myostatin levels)', 'timeFrame': '6 Months'}, {'measure': 'Changes in Stool microbiota for 20 patients', 'timeFrame': '6 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'The study will be conducted on patients attending /admitted to Department of Hepatology from April 2017 to December 2018 at ILBS, New Delhi .\n\nClinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Patients in treatment group will receive nutritional therapy in the form of 30-kcal/kg/day and 1.5gm/kg/day protein with supplements. Other patients will continue diet that they were receiving before along with lactulose. Previous treatment and prophylaxis of variceal bleed any (endoscopic variceal ligation or beta blocker) will be continued as before. All subjects will be followed up every month for treatment compliance and for development of any complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Liver cirrhosis (Child B or Child C class)\n2. Age between 18-60 years\n3. History of recovery from episodeof overt hepatic encephalopathy (West-Haven grade 1 and above) in last 12 months.\n\nExclusion Criteria:\n\n1. Evidence of overt hepatic encephalopathy at the time of enrollment\n2. History of taking lactulose, rifaximin, neomycin, metronidazole, L-Ornithine L-Aspartate or probiotics in past 7 days\n3. Alcohol intake during past 6 weeks\n4. Receiving secondary prophylaxis for spontaneous bacterial peritonitis\n5. Previous transjugular intrahepatic portosystemic shunts or shunt surgery\n6. Significant comorbid illness such as heart, respiratory or kidney failure, and neurological disease such as Alzheimer's disease, Parkinson's disease and non hepatic metabolic encephalopathies\n7. Receiving psychoactive drugs, promotility and hypomotility drugs\n8. Hepatocellular carcinoma\n9. Electrolyte abnormality (Serum sodium \\<125meq/L or serum potassium \\<2.5meq/L)\n10. Intercurrent infection such as spontaneous bacterial peritonitis\n11. Patients of acute on chronic liver failure (ACLF)."}, 'identificationModule': {'nctId': 'NCT03161106', 'briefTitle': 'To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis- A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'ILBS-Cirrhosis-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrional Therapy Group', 'description': 'Nutritional group- Protein of 1.5 gm/kg thrice daily for 6 months', 'interventionNames': ['Dietary Supplement: Nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lactulose Group', 'description': 'Lactulose - 20 mL thrice daily (maximum) for 6 months', 'interventionNames': ['Drug: Lactulose', 'Dietary Supplement: Diet']}], 'interventions': [{'name': 'Nutrition', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements', 'armGroupLabels': ['Nutrional Therapy Group']}, {'name': 'Lactulose', 'type': 'DRUG', 'description': 'Lactulose plus diet consumed by patient', 'armGroupLabels': ['Lactulose Group']}, {'name': 'Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Protein Powder 15 to 20 gm/meal/day', 'armGroupLabels': ['Lactulose Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}