NCT03087097: THRIVE

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

Terminated Phase 1 Last updated 13 January 2021

What this trial tests

Phase 1 trial testing Fecal Microbiota Transplantation in Severe Acute Malnutrition in 5 participants. Terminated before completion.

Timeline

11 April 2019

Primary endpoint
21 July 2020

21 July 2020

Quick facts

Lead sponsor	Microbiome Health Research Institute
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	5
Start date	11 April 2019
Primary completion	21 July 2020
Estimated completion	21 July 2020
Sites	1 location across South Africa

Drugs / interventions tested

• Fecal Microbiota Transplantation — full drug profile →

Conditions studied

• Severe Acute Malnutrition — all drugs for Severe Acute Malnutrition →
• Moderate Acute Malnutrition — all drugs for Moderate Acute Malnutrition →

Sponsor

Microbiome Health Research Institute

Who can join

Adults 12 Months to 60 Months, any sex, with Severe Acute Malnutrition or Moderate Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
2. Fecal microbiota transplantation: great potential with many challenges.
   Kellermayer R. · · 2019 · cited 29× · PMID 31231707 · DOI 10.21037/tgh.2019.05.10