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Completed

NCT Number: NCT02847481

A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • IBS with diarrhea

Treatment and study plan

Fecal Microbiota Transplantation

Procedure

fecal microbiota transplantation

placebo fecal microbiota transplantation

Drug

placebo fecal microbiota transplantation

FMT with antibiotic pre-treatment (v1)

Procedure

FMT with antibiotic pre-treatment (v1)

FMT with antibiotic pre-treatment (v2)

Procedure

FMT with antibiotic pre-treatment (v2)

Primary outcomes

  1. stable engraftment of donor microbiota

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • OpenBiome

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2016
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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