Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Last updated: August 1, 2017
Sponsor: Aleris-Hamlet Hospitaler København
Overall Status: Completed

Phase

2/3

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT02788071
H-15016343
  • Ages 18-60
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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

Exclusion

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, herniarepair, 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 asthmaagents, blood pressure and cholesterol lowering agents, proton pump inhibitors andnon-prescription medicines

  • Abnormal screening biochemistry

  • Abnormal colonoscopy findings

  • Pregnant, planned pregnancy or breastfeeding females

  • Ingestion of probiotics or antibiotics < 8 weeks before the inclusion Inclusion criteria for donors

  • 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 FormScale)

  • No medication consumption Exclusion criteria for donors

  • 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

Study Design

Total Participants: 52
Study Start date:
October 01, 2016
Estimated Completion Date:
July 31, 2017

Study Description

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.

Connect with a study center

  • Aleris Hamlet Hospitaler, København

    Copenhagen, Søborg 2760
    Denmark

    Site Not Available

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