Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating

NCT02299973 | Completed

• 1 other identifier: UGent_Gastro_001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Intestinal microbiota dysbiosis is thought to play an important role in the complex pathophysiology of irritable bowel syndrome (IBS), especially in diarrhoea-predominant IBS and possibly in IBS with severe bloating. Fecal microbiota transplantation or FMT has been shown to be an effective means of correcting this imbalance in the gut microbiota, especially in patients with recurrent Clostridium difficile infections where it has become a preferred treatment strategy. In a preliminary pilot study in 12 patients we found that FMT was a safe and accepted therapy in IBS patients. In 75% of patients an amelioration of IBS symptoms in general and abdominal bloating was seen three months after transplantation. In this study the effects of FMT on patients with IBS without constipation and bloating will be investigated in a double blind, placebo controlled RCT.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; fecal microbiota transplantation; bloating

Outcome Measures

Primary Outcomes (2)

• Reduction of overall IBS symptoms (Key question 1)

  On a weekly basis patients will assess their overall IBS symptoms by answering a key question (Are your overall symptoms improved as compared to before the treatment?)

  3 months after FMT

• Reduction of abdominal bloating (Key question 2)

  On a weekly basis patients will assess their sensation of abdominal bloating by answering a key question (Is your overall sensation of bloating improved by FMT as compared to before treatment?)

  3 months after FMT

Secondary Outcomes (7)

• Changes in fecal microbiome composition (Illumina sequencing)

  3 months after FMT

• Changes in IBS symptom scores at three months after FMT

  3 months after FMT

• Changes in IBS symptom scores at six months post FMT

  6 months

• Changes in IBS symtom scores at 9 months post FMT

  9 months

• Changes in IBS symptom scores at 1 year post FMT

  1 year

Study Arms (2)

Placebo group (FMT with own stool)

PLACEBO COMPARATOR

Fecal microbiota transplantation with patient's own stool

Procedure: FMT with own stool

Treatment group (FMT with donor stool)

EXPERIMENTAL

Fecal microbiota transplantation with healthy donor stool

Procedure: FMT with donor stool

Interventions

FMT with donor stool PROCEDURE

fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group

Also known as: Fecal microbiota transplantation with healthy donor stool

Treatment group (FMT with donor stool)

FMT with own stool PROCEDURE

fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group

Also known as: Fecal microbiota transplantation with own stool

Placebo group (FMT with own stool)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• signed informed consent
• Irritable bowel syndrome with predominant diarrhoea as defined by the ROME III criteria and with symptoms of abdominal bloating
• IBS symptom score \> 3 on at least 2 subscores (abdominal discomfort, abdominal bloating, abdominal pain, urgency, stool frequency, stool consistency)

You may not qualify if:

• predominant constipation as defined by Rome III criteria
• pregnancy or inadequate anti conception for the duration of the trial
• celiac disease
• any contra-indications for colonoscopy
• structural abnormalities of the colon (e.g. ileocecal resection, gastric bypass)
• severe gastro-intestinal comorbidities (e.g. IBD, coloncarcinoma)
• non gastro-intestinal malignancy
• severe psychiatric comorbidity which had important effects on the quality of life
• antimicrobial treatment 4 weeks prior to screening visit
• treatment with probiotics 2 weeks prior to screening visit
• recent diagnosis of lactose intolerance (\< 3 months before screening visit)
• any severe comorbidity that might interfere with the study course as determined by the treating physician
• age 18 - 75 years
• signed informed consent
• normal screening protocol which includes screening for infectious diseases (eg. blood HIV, Syphilis, Hepatitis B or C; stool: enteropathogens, clostridium, ESBL, CPE)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Publications (5)

• Dupont HL. Review article: evidence for the role of gut microbiota in irritable bowel syndrome and its potential influence on therapeutic targets. Aliment Pharmacol Ther. 2014 May;39(10):1033-42. doi: 10.1111/apt.12728. Epub 2014 Mar 25.

  PMID: 24665829 BACKGROUND

• Kassinen A, Krogius-Kurikka L, Makivuokko H, Rinttila T, Paulin L, Corander J, Malinen E, Apajalahti J, Palva A. The fecal microbiota of irritable bowel syndrome patients differs significantly from that of healthy subjects. Gastroenterology. 2007 Jul;133(1):24-33. doi: 10.1053/j.gastro.2007.04.005. Epub 2007 Apr 14.

  PMID: 17631127 BACKGROUND

• van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

  PMID: 23323867 BACKGROUND

• Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1.

  PMID: 23852569 BACKGROUND

• Holvoet T, Joossens M, Vazquez-Castellanos JF, Christiaens E, Heyerick L, Boelens J, Verhasselt B, van Vlierberghe H, De Vos M, Raes J, De Looze D. Fecal Microbiota Transplantation Reduces Symptoms in Some Patients With Irritable Bowel Syndrome With Predominant Abdominal Bloating: Short- and Long-term Results From a Placebo-Controlled Randomized Trial. Gastroenterology. 2021 Jan;160(1):145-157.e8. doi: 10.1053/j.gastro.2020.07.013. Epub 2020 Jul 15.

  PMID: 32681922 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

• Danny De Looze, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastro-enterologie

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 24, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

BE (1)