Clinical trial NCT02788071: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Fecal Microbiota Transplantation
Microbiota
Lead sponsor: Aleris-Hamlet Hospitaler København
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: University of Aarhus
First posted: 2016-06-02
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: symptoms score
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in microbiota diversity
timeFrame: Day 4, 4 weeks, 12 weeks and 24 weeks
measure: Microbiota diversity IBS patients
timeFrame: Baseline
measure: Microbiota diversity in healthy donors
timeFrame: Baseline
measure: Change in Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Questionnaire Scores
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Aleris Hamlet Hospitaler, København
state: Søborg
Study officials:
affiliation: Aleris-Hamlet Hospitaler København
name: Alice Højer Christensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.