Stanford University
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.
For this study, the research participant will receive a once daily oral dose of healthy young FMT and diet modification to increase fiber and fermented food consumption. Throughout the study's duration, the participant will provide stool, blood and urine samples as well as a series of health questionnaires to track the impact of the intervention. \*PROTOCOL OVERVIEW\* The study will begin with the selection of possible participants through the samples collected through the Stanford Microbiome Bank (IRB 85544), the participants identified will be contacted through the appropriate channels and…
Inclusion Criteria: * 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. * Willing to adhere to the study's lifestyle considerations for the duration of the study (maintain usual diet unless assigned to the diet arm; maintain usual physical activity; avoid non-essent…
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.
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.).
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
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