Skip to main content
OpenTrials
Completed

NCT Number: NCT02788071

Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Aleris Hamlet Hospitaler, København

Copenhagen, Søborg, 2760, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 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

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 Form Scale)
  • 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

Treatment and study plan

FMT capsules

Dietary Supplement

25 capsules per day for 12 days

FMT placebo

Dietary Supplement

25 capsules per day for 12 days

Primary outcomes

  1. symptoms score

    Time frame: 12 weeks

    Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)

Secondary outcomes

  1. Change in microbiota diversity

    Time frame: Day 4, 4 weeks, 12 weeks and 24 weeks

    Measured by DNA sequencing

  2. Microbiota diversity IBS patients

    Time frame: Baseline

    Measured by DNA sequencing

  3. Microbiota diversity in healthy donors

    Time frame: Baseline

    Measured by DNA sequencing. To compare with the recipients (IBS patients)

  4. Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores

    Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks

Sponsors and collaborators

Lead sponsor

Aleris-Hamlet Hospitaler København

Other

Collaborators

  • Hvidovre University Hospital
  • University of Aarhus

Registry information

Official study title

Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Aug 2, 2017

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.

Published trials that share one or more normalized conditions with this study.