Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in … (NCT03087097) | Clinical Trial Compass
TerminatedPhase 1
Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Patients in the Rehabilitative Phase of Malnutrition
Stopped: COVID-19 pandemic and resource constraints
South Africa5 participantsStarted 2019-04-11
Plain-language 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.
Who can participate
Age range12 Months – 60 Months
SexALL
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Inclusion criteria
✓. Age 12 to 60 months.
✓. Current diagnosis of malnutrition (defined as a WHZ less than -2 according to the WHO 2006 standards or a MUAC less than 125mm) with failure to respond nutritionally, defined as:
✓. HIV negative
✓. Received at last four weeks of optimal WHO treatment for malnutrition:
✓. Micronutrient supplementation (Vitamin A, zinc and iron) as recommended by local guidelines
✓. Nutritional rehabilitation as recommended by local guidelines.
✓. Written informed consent obtained by parent or caregiver.
Exclusion criteria
✕. Evidence of current complicated malnutrition defined as any of the following:
✕. Admitted to acute care ward as inpatient
✕. Signs of severe acute infection such as pneumonia, bacteremia, meningitis. Minor infections such as candida dermatitis, pharyngitis, upper respiratory tract infections will be eligible for inclusion at the discretion of the study physician.
✕. One or more WHO Integrated Management of Childhood Illness danger signs.(3)
✕. Failure to pass appetite test.
✕. Presence of known comorbid diseases such as pulmonary Tuberculosis on treatment, cystic fibrosis, type I diabetes mellitus, intestinal malabsorptive syndromes, chronic lung disease, chronic liver disease, chronic renal disease, chronic neurological diseases (e.g. cerebral palsy) or malignancy undergoing active chemotherapy.
✕. Bilateral pitting pedal edema or generalized anasarca
✕. Have taken antibiotics in the past seven days before the Day 0 visit or are anticipated to need antibiotics up to seven days before the Day 0 visit.