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NOT YET RECRUITING
NCT07912164
NA

Fecal Microbiota Transplantation (FMT) to Slow Biological Aging

Sponsor: Human Biome S.A.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate if multi-dose fecal microbiota transplantation (FMT) capsules can safely and effectively slow down biological aging and reduce chronic low-grade inflammation in adults aged 45 to 80 with metabolic neglect. The main questions it aims to answer are: * Can oral FMT capsules significantly slow the biological pace of aging as measured by the DunedinPACE epigenetic clock? * Can FMT successfully reduce chronic systemic inflammation (measured by markers such as suPAR, IL-6, and hs-CRP)? Researchers will compare participants receiving the active product to those receiving a matching placebo to see if the microbiome intervention improves metabolic health and cognitive function via the gut-brain axis. Participants will: * Undergo a short-term preparation phase involving targeted antibiotics and standard bowel cleansing. * Receive an 2 initial induction doses of active product (or placebo) followed by 5 regular booster cycles administered approximately every 4 weeks. * Attend periodic clinical visits for physical examinations, blood draws, stool sample collection (at home), and cognitive testing using the CANTAB platform and MoCA scale. * Maintain a participant diary to record adverse events (AE), product administration, stool sample collection, and dietary habits.

Official title: A Randomized, Double-blind, Placebo-controlled Research Study Evaluating the Efficacy and Safety of Multi-dose Fecal Microbiota Transplantation (FMT) in Capsule Form as an Intervention to Slow Down the Rate of Biological Aging.

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-12

Completion Date

2027-12

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

PROCEDURE

Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps)

Fecal microbiota transplantation (FMT) capsules administered in an initial induction phase followed by subsequent booster cycles. Frozen oral capsules containing full-spectrum human gut microbiota given as an initial induction (comprising a single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks.

PROCEDURE

PLACEBO for Fecal microbiota delivery through oral capsules

Placebo Capsules (Comparator): Frozen oral capsules identical in appearance, packaging, and dosing schedule to the active product, containing pharmacologically inert substances. Administered as an initial induction phase (single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks