Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: FMT capsules; Dietary supplement: FMT placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Søborg
    • Copenhagen, Søborg, Denmark, 2760
      • Aleris Hamlet Hospitaler, København

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FMT capsules	Dietary supplement: FMT capsules; 25 capsules per day for 12 days
Placebo Comparator: FMT placebo; Placebo capsules	Dietary supplement: FMT placebo; 25 capsules per day for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms score	Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiota diversity	Measured by DNA sequencing	Day 4, 4 weeks, 12 weeks and 24 weeks
Microbiota diversity IBS patients	Measured by DNA sequencing	Baseline
Microbiota diversity in healthy donors	Measured by DNA sequencing. To compare with the recipients (IBS patients)	Baseline
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores		Baseline, 4 weeks, 12 weeks and 24 weeks

Collaborators and Investigators

• Sponsor: Aleris-Hamlet Hospitaler København
• Collaborators: University of Aarhus; Hvidovre University Hospital
• Investigators: Principal Investigator: Alice Højer Christensen, MD, PhD, Aleris-Hamlet Hospitaler København

Publications and helpful links

General Publications

• Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: May 30, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Fecal Microbiota Transplantation; Microbiota
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: H-15016343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No