A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02847481

Enrollment

Registered

2016-07-28

Start date

2016-05-31

Completion date

2018-08-05

Last updated

2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

Fecal Microbiota Transplantation

Brief summary

This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.

Interventions

PROCEDUREfecal microbiota transplantation

fecal microbiota transplantation

DRUGplacebo fecal microbiota transplantation

placebo fecal microbiota transplantation

PROCEDUREFMT with antibiotic pre-treatment (v1)

FMT with antibiotic pre-treatment (v1)

PROCEDUREFMT with antibiotic pre-treatment (v2)

FMT with antibiotic pre-treatment (v2)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* IBS with diarrhea

Design outcomes

Primary

Measure	Time frame	Description
stable engraftment of donor microbiota	10 weeks	Stable engraftment will be defined with the Jensen-Shannon Divergence (JSD) between the bacteria community measured in the donor and recipient. Engraftment scores will be defined by the ratio between the JSD in comparison between the recipient and donor and the recipient and other healthy donors not providing material for their FMT.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026