Clinical Trials Logo
  1. Home
  2. Moderate Acute Malnutrition
  3. NCT03087097

Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition — THRIVE  

Severe Acute Malnutrition Clinical Trial

Official title:
Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema (THRIVE) for Patients in the Rehabilitative Phase of Malnutrition: A Pilot Study Evaluating Microbial Engraftment, Safety and Nutritional Outcomes

Clinical Trial Summary

This single-center, randomized, open-label trial will compare the safety of MTT delivered by rectal catheter enema in participants 12-60 months of age with malnutrition (moderate acute malnutrition [MAM] or severe acute malnutrition [SAM]) who are in the rehabilitative phase of treatment and have failed to respond to at least 4 weeks of standard therapy. Participants must meet inclusion criteria, no exclusion criteria prior to randomization. Participants will then be randomized in a 1:1 ratio at each site to 1 of 2 treatment groups: - MTT by rectal catheter enema: 10mL/kg (maximum 150mL, +/- 5ml) of healthy donor human intestinal microbiota will be infused. - Standard of care treatment for malnutrition as prescribed by local and national Department of Health Guidelines Participants will be evaluated through 56 days (±3) after randomization for primary outcomes (safety) as well as secondary outcomes (nutritional, clinical and microbiological response). Participant blood and urine samples will be collected at enrollment and day 56. Participant stool samples will be collected at enrollment and through days 3, 7, 21 and 56, thereafter, 3 months, 4 months, and 6 months. A caregiver stool sample will be collected at enrollment and day 56. Samples will be used for microbiome determination and other exploratory microbiological endpoints. An aliquot of donor stool will also be stored for microbiome determination and other exploratory microbiological endpoints and assessment of newly acquired infectious agents.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03087097
Study type Interventional
Source Microbiome Health Research Institute
Contact
Status Terminated
Phase Phase 1
Start date April 11, 2019
Completion date July 21, 2020
View Details
See also
  Status Clinical Trial Phase
Completed NCT03360877 - Prevention of Nosocomial Infections (CleanKids) N/A
Completed NCT04715204 - Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100 N/A
Not yet recruiting NCT06061484 - Modified Dosage for Severe Acute Malnutrition N/A
Not yet recruiting NCT06038071 - Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) N/A
Completed NCT03666572 - Pilot of a Prebiotic and Probiotic Trial in Young Infants With Severe Acute Malnutrition Phase 2
Completed NCT05020847 - Effectiveness of Alternative Diets During the Stabilization Phase on Children With Complicated SAM N/A
Completed NCT05015257 - Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor. N/A
Recruiting NCT06123390 - Evaluating RISQ System Implementation in Acutely Malnourished Children in Chad (CRIMSON) N/A
Completed NCT03370003 - Non-routine Use of Antibiotics (Amoxi-light)
Completed NCT03303131 - SAM: Discharge Based on the Use of a MUAC-based Criterion to N/A
Recruiting NCT06002438 - Eggs for Gut Health N/A
Terminated NCT05473234 - Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria Phase 3
Completed NCT01613547 - The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications N/A
Completed NCT01331044 - Ready to Use Therapeutic Food (RUTF) in Severe Malnourished Children N/A
Completed NCT03094247 - Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development N/A
Recruiting NCT04240990 - Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition N/A
Completed NCT01958905 - Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children N/A
Completed NCT05737472 - High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting N/A
Completed NCT03716115 - Therapeutic Approaches to Malnutrition Enteropathy Phase 2
Completed NCT01593969 - A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition Phase 2