Fecal Transplant + Diet for Aging
(ENGRAFT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to test whether young-donor fecal microbiome transplantation (FMT) and a fermented, plant-rich high-fiber, microbiome rejuvenating diet (MRD) reduce inflammatory and biological aging markers. Participants (≥40 years) will be randomized (1:1:1:1) for 8 weeks with 4-week follow-up to: (A) diet alone, (B) FMT alone, (C) diet + FMT, or (D) Placebo FMT. We will use rigorously screened young and healthy FMT donors and encapsulated delivery. Outcomes include change from baseline to end of dietary intervention (week 8) in markers of aging and inflammation. Secondary outcomes include defining microbiome engraftment/diversity/function, key metabolites, diet adherence, and quality-of-life.
Are You a Good Fit for This Trial?
This trial is for adults aged 40 and older who want to help study ways to reduce signs of aging and inflammation. People with certain health conditions or on medications that could interfere with the study may not be able to join.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Fecal Microbiota Transplant Capsules
- Microbiome Rejuvenating Diet
Trial Overview
The study compares four groups: a special high-fiber, plant-based diet; capsules containing gut bacteria from young donors (fecal transplant); both the diet and fecal transplant together; or placebo capsules. Participants are randomly assigned for 8 weeks.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Participants will receive a once daily dose (4 pills) of young donor fecal microbiome transplant (FMT) for two weeks and a microbiome rejuvenating diet (MRD) intervention for 8 weeks. The dietary intervention consists of dietitian-guided increase to \~3 servings/day fermented foods and ≥30-40 g/day or +20g fiber(plant-based whole food) and 5g of resistant starch and 5g of psyllium husk supplements over 8 weeks.
Participants will receive a once daily dose of young donor FMT for two weeks.
Participants receive placebo pills that are identical in shape size and feel to the active therapeutic daily for 2 weeks and will comply with a microbiome rejuvenating diet (MRD) for 8 weeks. The dietary intervention consists of dietitian-guided increase to \~3 servings/day fermented foods and ≥30-40 g/day or +20g fiber(plant-based whole food) and 5g of resistant starch and 5g of psyllium husk supplements over 8 weeks.
Participants receive placebo pills that are identical in shape size and feel to the active therapeutic daily for 2 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
University of Minnesota
Collaborator
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