Ecosystem Nourishment for Gut Restoration After Fecal Transplantation

Conditions

• Aging

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Fecal Microbiota Transplant Capsules — DRUG
  Each 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 — BEHAVIORAL
  Fiber 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
  Participants 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

Study Details

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.

Key Dates

First listed

Sep 17, 2026

Start date

Dec 31, 2026

Status verified

Sep 2026

Primary completion

Jan 31, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: FMT and Diet intervention
  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.
• Experimental: FMT
  Participants will receive a once daily dose of young donor FMT for two weeks.
• Active Comparator: Placebo FMT and diet
  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.
• Placebo Comparator: Placebo FMT
  Participants receive placebo pills that are identical in shape size and feel to the active therapeutic daily for 2 weeks

Primary Outcome Measure

Difference in DunedinPACE [ Time Frame: Baseline and 8 weeks ]

Central Contacts

• Sean P Spencer, MD PhD
  650-736-6555
  [email protected]
• Roujheen Sabetan, MPH
  650-498-8188
  [email protected]

Locations (1)

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