NCT03125564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 12, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2023

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

April 7, 2017

Last Update Submit

August 21, 2024

Conditions

Irritable Bowel SyndromeFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • the proportion of responders

    Response means a symptom relief of more than 50 points assessed by IBS-SSS.

    12 weeks

Secondary Outcomes (15)

  • The proportion of patients who had adequate relief of general IBS symptoms

    12 weeks

  • Assess the onset and duration of relief of general IBS symptoms

    12 weeks

  • The proportion of patients who had improvement on abdominal bloating

    12 weeks

  • Assess the onset and duration of abdominal bloating relief

    12 weeks

  • Assess the Abdominal pain between two groups

    12 weeks

  • +10 more secondary outcomes

Study Arms (2)

Fecal Microbiota Transplantation

EXPERIMENTAL

FMT infusion and Fecal and Mucosal Microbiota Assessment

Procedure: Fecal Microbiota TransplantationProcedure: Fecal and Mucosal Microbiota Assessment

Sham infusion

SHAM COMPARATOR

Infusion with sham and Fecal and Mucosal Microbiota Assessment

Procedure: ShamProcedure: Fecal and Mucosal Microbiota Assessment

Interventions

Fecal Microbiota TransplantationPROCEDURE

Fecal microbiota transplantation

Fecal Microbiota Transplantation
ShamPROCEDURE

Infusion of sham

Sham infusion
Fecal and Mucosal Microbiota AssessmentPROCEDURE

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

Fecal Microbiota TransplantationSham infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 000000, Hong Kong

Location

Related Publications (11)

  • 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.

    PMID: 15239910BACKGROUND

  • 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.

    PMID: 12241674BACKGROUND

  • 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.

    PMID: 24751910BACKGROUND

  • 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: 17631127BACKGROUND

  • 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.

    PMID: 23800182BACKGROUND

  • 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.

    PMID: 8544549BACKGROUND

  • 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.

    PMID: 16319671BACKGROUND

  • 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.

    PMID: 20236566BACKGROUND

  • 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.

    PMID: 21208106BACKGROUND

  • 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.

    PMID: 23718168BACKGROUND

  • 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.

    PMID: 37667968DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Fecal Microbiota Transplantationsalicylhydroxamic acidDefecation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Siew Ng, Prof.

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 24, 2017

Study Start

April 12, 2017

Primary Completion

September 16, 2022

Study Completion

December 16, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)