Effect of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

Aleris-Hamlet Hospitaler København

Status and phase: Completed; Phase 3; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: FMT placebo; Dietary Supplement: FMT capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT02788071

H-15016343

Details and patient eligibility

About

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).

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

FMT capsules

Experimental group

Description:

FMT capsules

Treatment:

Dietary Supplement: FMT capsules

FMT placebo

Placebo Comparator group

Description:

Placebo capsules

Treatment:

Dietary Supplement: FMT placebo