FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

NCT ID: NCT03125564

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-12
• Study Completion Date: 2023-12-16

Brief Summary

Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.

Detailed Description

Irritable bowel syndrome (IBS) is a common functional bowel disorder of the gastrointestinal tract affecting up to 20 percent of the adolescent and adult populations. It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating, and is associated with impaired quality of life. IBS can be categorised into diarrhoea predominant type (IBS-D), constipation predominant type (IBS-C), and mixed type (IBS-M). Until recently, the development of an effective therapy for this condition has been hampered by a poor understanding of the etiology of the disease. Traditionally the underlying pathogenesis of IBS has been centered on the brain-gut axis whereby stress and psychological conditions alter the perception of IBS symptoms. Emerging evidence however supports the observation that at least in a subgroup of patients with IBS, peripheral mechanisms within the intestine including low grade mucosal inflammation, abnormal immune activation and altered visceral sensitivity may be the main drivers of the manifestations in IBS.

Accumulating data suggest that the intestinal microbiota play an important role in the pathophysiology of IBS. This is derived from early observation that post-infectious IBS developed in a subgroup of patients following a bout of gastroenteritis. Several studies have shown that the fecal microbiota was altered in IBS and IBS symptoms can be improved by therapeutic interventions that target the microbiota including antibiotics, probiotics and prebiotics. Rifaximin, an oral, non-systemic broad spectrum antibiotics has also been shown to provide significant relief in IBS symptoms in a randomized controlled trial.

Fecal microbiota transplantation (FMT) defined as infusion of feces from healthy donors to affected subjects has shown impressive results with high cure rates in patients with recurrent clostridium difficile infections.The mechanism of FMT in IBS is not completely clear.

The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS.

Conditions

Irritable Bowel Syndrome; Fecal Microbiota Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fecal Microbiota Transplantation

FMT infusion and Fecal and Mucosal Microbiota Assessment

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: PROCEDURE

Fecal microbiota transplantation

Fecal and Mucosal Microbiota Assessment

Intervention Type: PROCEDURE

To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation

Sham infusion

Infusion with sham and Fecal and Mucosal Microbiota Assessment

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: PROCEDURE

Infusion of sham

Fecal and Mucosal Microbiota Assessment

Intervention Type: PROCEDURE

To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation

Fecal microbiota transplantation

Intervention Type: PROCEDURE

Sham

Infusion of sham

Intervention Type: PROCEDURE

Fecal and Mucosal Microbiota Assessment

To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients are aged 18 or above
• Patients have a diagnosis of IBS consistent with the Rome III criteria (13)
• Patients did not have adequate relief of global IBS symptoms and of IBS-related bloating at both the time of screening and the time of randomization
• Patients had undergone clinical investigations with colonoscopy within five years of recruitment
• Patients with written informed consent form provided

Exclusion Criteria

• Patients have constipation predominant IBS (according to the definition of Rome III criteria)
• Patients have a history of inflammatory bowel disease or gastrointestinal malignancy
• Patients have previous abdominal surgery (other than cholecystectomy or appendectomy)
• Patients have human immunodeficiency virus infection
• Patients have renal disease manifested by 1.5 times the ULN of serum creatinine or blood urea nitrogen level
• Patients have hepatic disease manifested by twice the upper limit of normal (ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin
• Patients have diabetes mellitus manifested by HbA1C > 6.5%
• Patients have abnormal thyroid function manifested by values of serum Sensitive Thyroid Stimulating Hormone and serum free T4 fall outside the reference range which is not controlled by thyroid medications
• Patients have a history of psychiatric illness (mania and schizophrenia)
• Patients have depression defined by having a Patient Health Questionnaire-9 (PHQ-9) score > 15
• Patients have anxiety defined by having a Generalized Anxiety Disorder 7 (GAD7) score > 10
• Patients have active infection at the time of inclusion
• Patients have used antibiotic therapy or anti-inflammatory drugs within the past 7 days
• Patients have any other organic causes that can explain the symptoms of IBS
• Current pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Siew Chien NG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siew Ng, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

References

Wilson S, Roberts L, Roalfe A, Bridge P, Singh S. Prevalence of irritable bowel syndrome: a community survey. Br J Gen Pract. 2004 Jul;54(504):495-502.

Reference Type: BACKGROUND

PMID: 15239910 (View on PubMed)

Talley NJ, Spiller R. Irritable bowel syndrome: a little understood organic bowel disease? Lancet. 2002 Aug 17;360(9332):555-64. doi: 10.1016/S0140-6736(02)09712-X.

Reference Type: BACKGROUND

PMID: 12241674 (View on PubMed)

Collins SM. A role for the gut microbiota in IBS. Nat Rev Gastroenterol Hepatol. 2014 Aug;11(8):497-505. doi: 10.1038/nrgastro.2014.40. Epub 2014 Apr 22.

Reference Type: BACKGROUND

PMID: 24751910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17631127 (View on PubMed)

Ng SC, Lam EF, Lam TT, Chan Y, Law W, Tse PC, Kamm MA, Sung JJ, Chan FK, Wu JC. Effect of probiotic bacteria on the intestinal microbiota in irritable bowel syndrome. J Gastroenterol Hepatol. 2013 Oct;28(10):1624-31. doi: 10.1111/jgh.12306.

Reference Type: BACKGROUND

PMID: 23800182 (View on PubMed)

Gwee KA, Graham JC, McKendrick MW, Collins SM, Marshall JS, Walters SJ, Read NW. Psychometric scores and persistence of irritable bowel after infectious diarrhoea. Lancet. 1996 Jan 20;347(8995):150-3. doi: 10.1016/s0140-6736(96)90341-4.

Reference Type: BACKGROUND

PMID: 8544549 (View on PubMed)

Spiller R, Campbell E. Post-infectious irritable bowel syndrome. Curr Opin Gastroenterol. 2006 Jan;22(1):13-7. doi: 10.1097/01.mog.0000194792.36466.5c.

Reference Type: BACKGROUND

PMID: 16319671 (View on PubMed)

Parkes GC, Sanderson JD, Whelan K. Treating irritable bowel syndrome with probiotics: the evidence. Proc Nutr Soc. 2010 May;69(2):187-94. doi: 10.1017/S002966511000011X. Epub 2010 Mar 18.

Reference Type: BACKGROUND

PMID: 20236566 (View on PubMed)

Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.

Reference Type: BACKGROUND

PMID: 21208106 (View on PubMed)

van Nood E, Dijkgraaf MG, Keller JJ. Duodenal infusion of feces for recurrent Clostridium difficile. N Engl J Med. 2013 May 30;368(22):2145. doi: 10.1056/NEJMc1303919. No abstract available.

Reference Type: BACKGROUND

PMID: 23718168 (View on PubMed)

Yau YK, Su Q, Xu Z, Tang W, Ching JYL, Mak JWY, Cheung CP, Fung M, Ip M, Chan PKS, Wu JCY, Chan FKL, Ng SC. Randomised clinical trial: Faecal microbiota transplantation for irritable bowel syndrome with diarrhoea. Aliment Pharmacol Ther. 2023 Oct;58(8):795-804. doi: 10.1111/apt.17703. Epub 2023 Sep 5.

Reference Type: DERIVED

PMID: 37667968 (View on PubMed)

Other Identifiers

FMT-IBS study

Identifier Type: -

Identifier Source: org_study_id