We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02788071
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : August 2, 2017
Sponsor:
Collaborators:
Hvidovre University Hospital
University of Aarhus
Information provided by (Responsible Party):
Alice Højer Christensen, Aleris-Hamlet Hospitaler København

Tracking Information
First Submitted Date  ICMJE May 30, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date August 2, 2017
Study Start Date  ICMJE October 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2016)		 symptoms score [ Time Frame: 12 weeks ]
Measured by the Irritable bowel syndrome - severity symptom score (IBS-SSS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2016)
  • Change in microbiota diversity [ Time Frame: Day 4, 4 weeks, 12 weeks and 24 weeks ]
    Measured by DNA sequencing
  • Microbiota diversity IBS patients [ Time Frame: Baseline ]
    Measured by DNA sequencing
  • Microbiota diversity in healthy donors [ Time Frame: Baseline ]
    Measured by DNA sequencing. To compare with the recipients (IBS patients)
  • Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Official Title  ICMJE Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome (IBS) - a Randomized, Double-blind Placebo Controlled Pilot Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Dietary Supplement: FMT capsules
    25 capsules per day for 12 days
  • Dietary Supplement: FMT placebo
    25 capsules per day for 12 days
Study Arms  ICMJE
  • Experimental: FMT capsules
    FMT capsules
    Intervention: Dietary Supplement: FMT capsules
  • Placebo Comparator: FMT placebo
    Placebo capsules
    Intervention: Dietary Supplement: FMT placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2016)		 52
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02788071
Other Study ID Numbers  ICMJE H-15016343
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Alice Højer Christensen, Aleris-Hamlet Hospitaler København
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aleris-Hamlet Hospitaler København
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hvidovre University Hospital
  • University of Aarhus
Investigators  ICMJE
Principal Investigator: Alice Højer Christensen, MD, PhD Aleris-Hamlet Hospitaler København
PRS Account Aleris-Hamlet Hospitaler København
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP