MedTrace Logo

Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating

NCT02299973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-12-08

No results posted yet for this study

Summary

Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy.

In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation.

In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT.

Conditions

  • Irritable Bowel Syndrome

Interventions

PROCEDURE

FMT with donor stool

fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group

PROCEDURE

FMT with own stool

fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Danny De Looze, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02299973 on ClinicalTrials.gov