Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788071
• Other study ID #: H-15016343
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 30, 2016
• Last updated: August 1, 2017
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Aleris-Hamlet Hospitaler København
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• FMT capsules
25 capsules per day for 12 days
• FMT placebo
25 capsules per day for 12 days

Locations

Country	Name	City	State
Denmark	Aleris Hamlet Hospitaler, København	Copenhagen	Søborg

Sponsors (3)

Lead Sponsor	Collaborator
Aleris-Hamlet Hospitaler København	Hvidovre University Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptoms score	Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)	12 weeks
Secondary	Change in microbiota diversity	Measured by DNA sequencing	Day 4, 4 weeks, 12 weeks and 24 weeks
Secondary	Microbiota diversity IBS patients	Measured by DNA sequencing	Baseline
Secondary	Microbiota diversity in healthy donors	Measured by DNA sequencing. To compare with the recipients (IBS patients)	Baseline
Secondary	Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores		Baseline, 4 weeks, 12 weeks and 24 weeks