Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-27 @ 1:38 PM
Study NCT ID:
NCT06447220
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2024-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Washed Microbiota Transplantation for Malnutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'fecal, blood and urine samples before and 12 weeks after washed microbiota transplantation'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2024-05-19', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of the third lumbar vertebrae skeletal muscle mass and height', 'timeFrame': 'baseline, 12 weeks post transplantation', 'description': 'The third lumbar vertebrae skeletal muscle mass represents the sum of the cross-sectional areas of the skeletal muscles at the L3 level, including the psoas major, the erector spinae, the quadratus lumborum, the musculus transversus abdominis, the obliquus externus abdominis and the obliquus internus abdominis. Skeletal muscle mass and height will be combined to report the third lumbar vertebrae skeletal muscle mass index(L3 SMI) in cm\\^2/m\\^2.'}, {'measure': 'change of weight and height', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks post transplantation', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2.'}], 'secondaryOutcomes': [{'measure': "change of the 5-level EuroQoL Group's 5-dimension (EQ-5D-5L)", 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks post transplantation', 'description': 'EQ-5D-5L is a 5-dimension questionnaire measuring health state and each dimension represents the level from 1 to 5, with higher level indicating worse health state.'}, {'measure': 'change of the Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks post transplantation', 'description': 'PSQI is a self-rated questionnaire which assesses sleep quality over a 1-month time interval. Nineteen items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for seven components yields one global score, with higher score indicating worse sleep quality.'}, {'measure': 'change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks post transplantation', 'description': 'FACIT-Fatigue is a 13-item test measuring fatigue and each item receives a value from 0 to 4, with higher value indicating worse fatigue state.'}, {'measure': 'change of the Gastrointestinal Symptom Rating Scale(GSRS)', 'timeFrame': 'baseline, 4 weeks, 8 weeks, 12 weeks post transplantation', 'description': 'GSRS is a 13-item test to make a comprehensive assessment of common gastrointestinal symptom and each item receives a value from 0 to 3, with higher value indicating worse gastrointestinal condition.'}, {'measure': 'change of insulin-like growth factor I(IGF-I)', 'timeFrame': 'baseline, 12 weeks post transplantation', 'description': 'Blood is tested for Insulin-like growth factor I.'}, {'measure': 'the difference of the gut microbiota composition before and after washed microbiota transplantation', 'timeFrame': 'baseline, 12 weeks post transplantation', 'description': 'The composition of the gut microbiota is evaluated by sequencing faecal metagenome. We evaluate the differences in the structure of the flora and its metabolism.'}, {'measure': 'the incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0', 'timeFrame': '12 weeks post transplantation', 'description': 'The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['washed microbiota transplantation', 'malnutrition', 'fecal microbiota transplantation'], 'conditions': ['Malnutrition']}, 'referencesModule': {'references': [{'pmid': '30541096', 'type': 'BACKGROUND', 'citation': 'Miller J, Wells L, Nwulu U, Currow D, Johnson MJ, Skipworth RJE. Validated screening tools for the assessment of cachexia, sarcopenia, and malnutrition: a systematic review. Am J Clin Nutr. 2018 Dec 1;108(6):1196-1208. doi: 10.1093/ajcn/nqy244.'}, {'pmid': '36716756', 'type': 'BACKGROUND', 'citation': 'Dent E, Wright ORL, Woo J, Hoogendijk EO. Malnutrition in older adults. Lancet. 2023 Mar 18;401(10380):951-966. doi: 10.1016/S0140-6736(22)02612-5. Epub 2023 Jan 27.'}, {'pmid': '37322020', 'type': 'BACKGROUND', 'citation': 'Fontaine F, Turjeman S, Callens K, Koren O. The intersection of undernutrition, microbiome, and child development in the first years of life. Nat Commun. 2023 Jun 15;14(1):3554. doi: 10.1038/s41467-023-39285-9.'}, {'pmid': '34303552', 'type': 'BACKGROUND', 'citation': 'Coley EJL, Hsiao EY. Malnutrition and the microbiome as modifiers of early neurodevelopment. Trends Neurosci. 2021 Sep;44(9):753-764. doi: 10.1016/j.tins.2021.06.004. Epub 2021 Jul 21.'}, {'pmid': '33826814', 'type': 'BACKGROUND', 'citation': 'Chen RY, Mostafa I, Hibberd MC, Das S, Mahfuz M, Naila NN, Islam MM, Huq S, Alam MA, Zaman MU, Raman AS, Webber D, Zhou C, Sundaresan V, Ahsan K, Meier MF, Barratt MJ, Ahmed T, Gordon JI. A Microbiota-Directed Food Intervention for Undernourished Children. N Engl J Med. 2021 Apr 22;384(16):1517-1528. doi: 10.1056/NEJMoa2023294. Epub 2021 Apr 7.'}, {'pmid': '34746161', 'type': 'BACKGROUND', 'citation': "Xiang L, Yu Y, Ding X, Zhang H, Wen Q, Cui B, Zhang F. Exclusive Enteral Nutrition Plus Immediate vs. Delayed Washed Microbiota Transplantation in Crohn's Disease With Malnutrition: A Randomized Pilot Study. Front Med (Lausanne). 2021 Oct 22;8:666062. doi: 10.3389/fmed.2021.666062. eCollection 2021."}]}, 'descriptionModule': {'briefSummary': "Malnutrition is a pathological condition in which dietary intake fails to meet the body's energetic or nutritional needs. It may be caused by macronutrient or micronutrient deficiencies, high energy expenditure, impaired nutrient absorption or assimilation. Malnutrition can affect all stages of life. In adults, malnutrition is strongly associated with poor clinical outcomes such as increased morbidity, increased mortality and prolonged hospitalization. In children, malnutrition can lead to growth retardation, cognitive impairment and immune dysfunction.", 'detailedDescription': "The gut microbiota of malnourished patients is different from that of healthy people. The diversity of the gut microbiota of patients with severe malnutrition reduced and the abundance of Proteobacteria significantly increased, as well as pathogenic genera such as Klebsiella, Escherichia coli, Shigella, and Streptococcus. This suggests that gut microbiota plays an important role in the occurrence and development of malnutrition. Dietary intervention targeting gut microbiota can quickly improve children's malnutrition, promote weight gain and increase protein levels that promote bone growth and nerve development. Exclusive enteral nutrition combined with immediate washed microbiota transplantation(WMT) can rapidly improve the nutritional status of patients with Crohn's disease compared with those with delayed WMT. Gut microbiota has been confirmed to be closely related to malnutrition. Improving the disordered gut microbiota in malnourished patients may become a potential treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with malnutrition receiving WMT will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old;\n2. Meet any of the following two conditions: ①weight loss (\\>5% weight loss in the past 6 months or \\>10% weight loss in more than 6 months); ②low BMI (\\<70 years old and BMI\\<18.5kg/m2 or ≥70 years old and BMI\\<22kg/m2);\n3. Underwent washed microbiota transplantation.\n\nExclusion Criteria:\n\n1. Expected survival time \\<3 months;\n2. Women who are pregnant or breastfeeding;\n3. Other patients deemed not suitable for enrollment by the investigator.'}, 'identificationModule': {'nctId': 'NCT06447220', 'briefTitle': 'Washed Microbiota Transplantation for Malnutrition', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Washed Microbiota Transplantation for Malnutrition', 'orgStudyIdInfo': {'id': 'WMT-MN-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The malnourished undergoing washed microbiota transplantation', 'description': 'patients undergoing washed microbiota transplantation who were diagnosed as malnutrition according to weight loss or low BMI', 'interventionNames': ['Procedure: washed microbiota transplantation']}, {'label': 'The malnourished not undergoing washed microbiota transplantation', 'description': 'The malnourished patients did not undergo washed microbiota transplantation'}], 'interventions': [{'name': 'washed microbiota transplantation', 'type': 'PROCEDURE', 'otherNames': ['fecal microbiota transplantation'], 'description': "The prepared microbiota suspension was infused into the patients' gut.", 'armGroupLabels': ['The malnourished undergoing washed microbiota transplantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-025-58509883'}], 'facility': 'Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-025-58509883'}, {'name': 'Bota Cui, PhD', 'role': 'CONTACT', 'email': 'cuibota@njmu.edu.cn', 'phone': '086-025-58509884'}], 'overallOfficials': [{'name': 'Faming Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}