Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to investigate if fecal microbiota transplantation (FMT) will result in improvement in clinical outcome in patients with irritable bowel syndrome (IBS).

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Detailed Description

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Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal condition. IBS is associated with a high use of health-care costs and can substantially reduce quality of life and work productivity.

Several studies have demonstrated that the composition of the gut microbiota in IBS patients is different from healthy controls.

Fecal microbiota transplantation (FMT) could therefore be a treatment option for IBS patients by exchanging the microbiota of an IBS patient with the microbiota of a healthy donor.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FMT capsules

Group Type EXPERIMENTAL

FMT capsules

Intervention Type DIETARY_SUPPLEMENT

25 capsules per day for 12 days

FMT placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

FMT placebo

Intervention Type DIETARY_SUPPLEMENT

25 capsules per day for 12 days

Interventions

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FMT capsules

25 capsules per day for 12 days

Intervention Type DIETARY_SUPPLEMENT

FMT placebo

25 capsules per day for 12 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Fulfilled Rome III diagnostic criteria for IBS
* Moderate-severe disease activity (IBS-Symptom Severity Score ≥175)
* Able to read and speak Danish
* Normal colonoscopy at age ≥ 40 years (performed within 1 year) or blood in stool

* Age between 18-45 years
* Past and current healthy
* Normal weight (BMI between 18,5-24,9 kg/m2)
* Normal bowel movements (defined as 1-2 per day and type 3-4 at Bristol Stool Form Scale)
* No medication consumption

Exclusion Criteria

* Other chronic gastrointestinal disease
* Positive fecal sample with enteropathogenic microorganisms or Clostridium difficile
* Positive screening for HIV, Hepatitis B or HCV antibody
* Surgical interventions in the gastrointestinal region (except for appendectomy, hernia repair, cholecystectomy, and gynecological and urological procedures)
* Psychiatric disorder
* Fecal calprotectin ≥ 50 mg/kg
* Abuse of alcohol or drugs
* Medications other than birth control pills, hormone supplements, allergies and asthma agents, blood pressure and cholesterol lowering agents, proton pump inhibitors and non-prescription medicines
* Abnormal screening biochemistry
* Abnormal colonoscopy findings
* Pregnant, planned pregnancy or breastfeeding females
* Ingestion of probiotics or antibiotics \< 8 weeks before the inclusion

* Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
* Positive stool sample for C. difficile toxin, parasites or other pathogens
* Antibiotic treatment in the past 6 months
* Abuse of alcohol or drugs
* Smoking
* Tattoo or body piercing within the last 6 months
* Allergy, asthma or eczema
* Family history of gastrointestinal diseases
* Participation in high-risk sexual behaviors
* Born by Caesarean section

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No