Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema for Severe Acute Malnutrition (THRIVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03087097|
Recruitment Status : Not yet recruiting
First Posted : March 22, 2017
Last Update Posted : November 20, 2018
This single-center, randomized, double-blinded trial will compare the safety and efficacy of FMT given enema in subjects 18-60 months of age with uncomplicated, non-edematous SAM not responsive to standard therapy. Subjects must meet inclusion criteria, no exclusion criteria prior to randomization. Subjects will then be randomized by stratified random sampling (by age, diarrhea, MUAC and hyponatremia) in a 1:1 ratio at each site to 1 of 2 treatment groups:
- FMT by enema: 10mL/kg (maximum 60mL) of donor fecal material will be infused.
- Placebo by enema: 10mL/kg (maximum 60mL) of placebo material will be infused.
Subjects will be evaluated through 56 days (±5) after randomization for primary outcomes (safety) as well as secondary outcomes (nutritional, clinical and microbiological response). See definition under endpoints/outcome measures above).
Stool samples will be collected at enrollment and through days 3, 7, 14, 21, 42 and 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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Acute Malnutrition||Biological: Fecal Microbiota Transplant Biological: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Transfer of Healthy Gut Flora for Restoration of Intestinal Microbiota Via Enema (THRIVE) for Severe Acute Malnutrition: A Pilot Study Evaluating Microbial Engraftment, Safety and Nutritional Outcomes|
|Estimated Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: Fecal Microbiota Transplant
FMT by enema: 10mL/kg (maximum 150mL) of donor fecal material will be infused.
Biological: Fecal Microbiota Transplant
The investigational agent consists of screened-donor fecal material prepared for FMT. FMT will be administered using frozen screened-donor liquid stool (the investigational agent) in the form of enemas (60mL preparations) as per the published protocol in infants. 10mL/kg (maximum 60mL) of donor fecal material will be infused.
Placebo Comparator: Placebo
Placebo by enema: 10mL/kg (maximum 150mL) of placebo material will be infused.
Placebo will be administered via enema as per delivery of FMT, using standardized placebo preparation. 10mL/kg (maximum 60mL) of placebo material will be infused.
- Safety of FMT compared to placebo delivered by enema [ Time Frame: 56 days ]Proportion of participants with a severe adverse event (SAE) grade 2 or above (according to NIH grading)
- Stable engraftment of donor microbiota [ Time Frame: 56 days ]Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.
- Normalization of leptin, a biomarker correlated with disease status and mortality in SAM [ Time Frame: 56 days ]Serology collected at baseline and end-line will be cryopreserved and analyzed by immunoassay for leptin, a biomarker predicting survival in SAM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087097
|Contact: Majdi Osman, MD MPH||617-575-2201 ext email@example.com|