Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial.

NCT02154867 | Completed Phase 2

• 1 other identifier: 2013/971/REK
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Fecal Microbial Transplantation in Treatment of Irritable Bowel Syndrome; a Double Blinded Placebo Controlled Trial - the REFIT project Irritable bowel syndrome (IBS) is a condition characterized by variable complaints like diarrhoea, bloating and abdominal pain, and may result in considerably reduced quality of life and increased sickness absence. The prevalence of IBS in the general population may be as high as 15 per cent depending on the diagnostic criteria used. The pathophysiology of IBS is poorly understood and theories of visceral hypersensitivity, micro-inflammation and other less well founded theories have been stated. So far, no measurement or test can affirm diagnosis, but exclusion of organic diseases in combination with a typical symptom pattern according to the Rome classification can set the diagnosis. Earlier non-controlled case reports have shown a convincing effect of fecal microbial transplantation (FMT) in IBS patients. However, no placebo controlled trial has been performed in this condition. Changes in the gut microbiome may be an important factor in IBS pathogenesis. Microbiome analysis has revealed changes in microbiome composition that may trigger changes in visceral sensibility and pain perception. The fecal microbial transplantation (FMT) procedure has been used primarily to treat clostridium difficile infections. Few minor side effects have been reported. Hypothesis: IBS is caused by an imbalance of the gut microbiome that may be reset by transplanting a microbiome sample from a healthy donor. Aim of study:

• To test the clinical effect of FMT in patients with IBS
• To describe the fecal microbiome in IBS patients
• To describe changes in the fecal microbiome of IBS patients following FMT The REFIT study will perform a randomized placebo-controlled double blinded trial of FMT on IBS according to the Rome 3 criteria. A study group of 60 IBS (diarrhoea variant) patients will recruited from general practice and allocated to active (30) or placebo (30) by block randomization. Donors will be 15 healthy volunteers with no risk behaviour and a pre-screening for communicable diseases will be performed. Outcome measures will be clinical assessment by IBS-severity scoring system (IBS-SSS) at 0, 1, 3, 6, and 12 months. Microbiome analysis will be performed by metagenomic sequencing (University of Tromsø) at 0, 3, and 12 months for patients, and at inclusion for donors.

Conditions

Irritable Bowel Syndrome

Keywords

IBS-D; FMT; metagenomics; gut microbiome

Outcome Measures

Primary Outcomes (1)

• Change in subjective symptom score

  Comparison of Irritable bowel syndrome severity scoring system (IBS-SSS) grade assessment before and after fecal transplantation

  at 0 and 3 months

Secondary Outcomes (3)

• Microbiome profile change

  at 0, 3 and 12 months

• Long term effects of fecal transplantation

  at 12 months

• Safety of fecal transplantation in IBS

  during study period (0-12 months)

Study Arms (2)

Fecal transplantation

EXPERIMENTAL

Fecal transplantation of freshly prepared feces from healthy donor. Application by colonoscope in proximal half of colon.

Biological: Fecal transplantation

Placebo fecal transplantation

PLACEBO COMPARATOR

Sham transplant subject's own feces. Application by colonoscope in proximal part of colon.

Other: Placebo fecal transplant

Interventions

Fecal transplantation BIOLOGICAL

Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.

Also known as: Fecal microbial transplantation

Fecal transplantation

Placebo fecal transplant OTHER

Fecal transplantation with own feces

Placebo fecal transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with IBS-D according to Roma 3 criteria

You may not qualify if:

• Immunomodulating medication
• Nocturnal abdominal pain
• Constant abdominal pain
• Alarm symptoms like rectal bleeding, weight loss, nightsweats
• Symptomatic heart/vascular/lung disease
• Renal failure
• Known food allergy
• Microscopic/collagenous colitis
• non-compliant
• BMI \<18
• healthy volunteers
• Tattoos, imprisoning or piercing last 3 months
• Any history of chronic diarrhoea, constipation, inflammatory bowel disease, irritable bowel disease, colorectal polyps or cancer, immunosuppression, morbid obesity, metabolic syndrome, atopica, or fatigue
• positive test for hepatitis B, C, HIV, treponema pallidum
• sexual high risk habits

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Harstad, 9406, Norway

Location

Related Publications (2)

• Goll R, Johnsen PH, Hjerde E, Diab J, Valle PC, Hilpusch F, Cavanagh JP. Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome. Gut Microbes. 2020 Nov 9;12(1):1794263. doi: 10.1080/19490976.2020.1794263.

  PMID: 32991818 DERIVED

• Johnsen PH, Hilpusch F, Cavanagh JP, Leikanger IS, Kolstad C, Valle PC, Goll R. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):17-24. doi: 10.1016/S2468-1253(17)30338-2. Epub 2017 Nov 1.

  PMID: 29100842 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Rasmus Goll, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Per C Valle, PhD

  University Hospital of North Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: June 3, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2015-01

Locations

NO (1)