Ecosystem Nourishment for Gut Restoration After Fecal Transplantation
ConditionAging
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorStanford University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able and willing to provide written informed consent prior to completion of any study procedures.
Age ≥40 years at the time of consent.
In generally good health, as determined by medical history, medication review, and investigator assessment.
Willing and able to comply with all study procedures, assessments, and study-related restrictions for the duration of participation.
Disqualifiers
Moderate or severe irritable bowel syndrome (IBS).
Current or prior diagnosis of inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or indeterminate colitis.
Active gastrointestinal disease, including infectious gastroenteritis, colitis, gastritis, recurrent Clostridioides difficile infection, untreated Helicobacter pylori infection, or clinically significant malabsorption disorders (e.g., celiac disease).
Major gastrointestinal surgery within the past 5 years (excluding cholecystectomy and appendectomy), or history of major bowel resection at any time.
Trial design
Design model
Factorial
Treatments tested in this trial
Fecal Microbiota Transplant Capsules
DrugEach dose (4 capsules) will be taken daily in the morning on an empty stomach. Clear liquids are allowed and regular breakfast can follow one hour later. If the dose is skipped, the missed dose should be skipped and the standard 4-capsule dose resumed the following morning; doses must not be doubled. There should be no solid food at the time of ingestion , solid food should be avoided at least 4 hours prior to ingestion of capsules, however, liquid diet is always allowed and a full glass of water should be taken after every dose ingestion. The treatment will be administered daily for 2 weeks.
Microbiome Rejuvenating Diet
BehavioralFiber intake: participants will be instructed to increase their fiber intake to \>30/40g or +20g per day . There will be a 1 week ramp-up period in which participants will increase their intake progressively. Detailed instructions will be provided to include a variety of fiber sources (legumes, seeds, whole grains, nuts, vegetables, and fruits). Participants will also be instructed to include 5g of resistant starch supplements and 5g of psyllium husk in their diet. Fermented food intake: participants will be instructed to add at least 3 portions of fermented food into their daily diet. There will be a 1 week ramp-up period in which participants will increase their intake progressively and maintain a high level of consumption for the following 8 weeks. Detailed instructions will be provided to include a variety of fermented foods (fermented dairy products, fermented vegetables, fermented non-alcoholic drinks, etc.).
Placebo Fecal Microbiota Transplantation
Other interventionParticipants will receive a once daily dose (4 pills) of inactive pills that are identical in size, shape, color, taste and feel to the active FMT pills
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: FMT and Diet interventionExperimental treatment 2 interventions
Group B: FMTExperimental treatment 1 intervention
Group C: Placebo FMT and dietActive comparator 2 interventions
Group D: Placebo FMTPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Difference in DunedinPACE
Difference in the 8-week change from baseline in DunedinPACE among the four randomized groups (FMT + MRD, FMT alone, MRD + placebo FMT, and placebo FMT), assessed by DNA methylation analysis of whole blood. DunedinPACE is a DNA methylation biomarker that quantifies the pace of biological aging, reported as a rate of biological aging per chronological year; higher values indicate a faster pace of aging and lower values indicate a slower pace.
Time frame
Baseline and 8 weeksSecondary outcomes
1
Difference in Epigenetic Age
Difference in the 8-week change from baseline in epigenetic age among the four randomized groups (FMT + MRD, FMT alone, MRD + placebo FMT, and placebo FMT), assessed by epigenetic clocks (PC GrimAge, PC PhenoAge, and Horvath).
Time frame
Baseline and 8 weeks2
Difference in Telomere Length
Difference in the 8-week change from baseline in telomere length among the four randomized groups (FMT + MRD, FMT alone, MRD + placebo FMT, and placebo FMT), assessed by DNA methylation-based estimation.
Time frame
Baseline and 8 weeks3
Difference in Gut Microbial Alpha Diversity
Difference in the 8-week change from baseline in gut microbial alpha diversity among the four randomized groups (FMT + MRD, FMT alone, MRD + placebo FMT, and placebo FMT), assessed by the Shannon diversity index from shotgun metagenomic sequencing of stool.
Time frame
Baseline and 8 weeks4
Difference in Interleukin-6 (IL-6)
Difference in the 8-week change from baseline in Interleukin-6 (IL-6) among the four randomized groups (FMT + MRD, FMT alone, MRD + placebo FMT, and placebo FMT).
Time frame
Baseline and 8 weeksSponsors and contacts
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Stanford University
Lead sponsor
University of Minnesota
Collaborator
Source ClinicalTrials.gov
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