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Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
FMT capsules
FMT placebo
Sponsored by
Aleris-Hamlet Hospitaler København
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aleris Hamlet Hospitaler, København

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FMT capsules

FMT placebo

Arm Description

FMT capsules

Placebo capsules

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in microbiota diversity
Measured by DNA sequencing
Microbiota diversity IBS patients
Measured by DNA sequencing
Microbiota diversity in healthy donors
Measured by DNA sequencing. To compare with the recipients (IBS patients)
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores

Full Information

First Posted
May 30, 2016
Last Updated
August 1, 2017
Sponsor
Aleris-Hamlet Hospitaler København
Collaborators
Hvidovre University Hospital, University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02788071
Brief Title
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Official Title
Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aleris-Hamlet Hospitaler København
Collaborators
Hvidovre University Hospital, University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Fecal Microbiota Transplantation, Microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FMT capsules
Arm Type
Experimental
Arm Description
FMT capsules
Arm Title
FMT placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
FMT capsules
Intervention Description
25 capsules per day for 12 days
Intervention Type
Dietary Supplement
Intervention Name(s)
FMT placebo
Intervention Description
25 capsules per day for 12 days
Primary Outcome Measure Information:
Title
symptoms score
Description
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in microbiota diversity
Description
Measured by DNA sequencing
Time Frame
Day 4, 4 weeks, 12 weeks and 24 weeks
Title
Microbiota diversity IBS patients
Description
Measured by DNA sequencing
Time Frame
Baseline
Title
Microbiota diversity in healthy donors
Description
Measured by DNA sequencing. To compare with the recipients (IBS patients)
Time Frame
Baseline
Title
Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores
Time Frame
Baseline, 4 weeks, 12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Højer Christensen, MD, PhD
Organizational Affiliation
Aleris-Hamlet Hospitaler København
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aleris Hamlet Hospitaler, København
City
Copenhagen
State/Province
Søborg
ZIP/Postal Code
2760
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
29980607
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

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