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A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

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ClinicalTrials.gov Identifier: NCT02847481
Recruitment Status : Active, not recruiting
First Posted : July 28, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
OpenBiome
Information provided by (Responsible Party):
Anthony Lembo, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Procedure: fecal microbiota transplantation Drug: placebo fecal microbiota transplantation Procedure: FMT with antibiotic pre-treatment (v1) Procedure: FMT with antibiotic pre-treatment (v2) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Fecal Microbiota Transplantation Engraftment in Irritable Bowel Syndrome
Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: fecal microbiota transplantation
fecal microbiota transplantation
Procedure: fecal microbiota transplantation
fecal microbiota transplantation

Placebo Comparator: placebo fecal microbiota transplantation
placebo fecal microbiota transplantation
Drug: placebo fecal microbiota transplantation
placebo fecal microbiota transplantation

Experimental: FMT after antibiotic pretreatment v1
fecal microbiota transplantation after antibiotic pretreatment
Procedure: fecal microbiota transplantation
fecal microbiota transplantation

Procedure: FMT with antibiotic pre-treatment (v1)
FMT with antibiotic pre-treatment (v1)

Experimental: FMT after antibiotic pretreatment v2
fecal microbiota transplantation after antibiotic pretreatment
Procedure: fecal microbiota transplantation
fecal microbiota transplantation

Procedure: FMT with antibiotic pre-treatment (v2)
FMT with antibiotic pre-treatment (v2)




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IBS with diarrhea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02847481


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
OpenBiome
Investigators
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Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center

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Responsible Party: Anthony Lembo, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02847481     History of Changes
Other Study ID Numbers: 2015P000211
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Anthony Lembo, Beth Israel Deaconess Medical Center:
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents