Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03125564
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE April 7, 2017
First Posted Date  ICMJE April 24, 2017
Last Update Posted Date July 18, 2018
Actual Study Start Date  ICMJE April 12, 2017
Estimated Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
The proportion of responder [ Time Frame: 12 weeks ]
Record 1) worst abdominal pain and 2)stool consistency everyday
Original Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
The proportion of responder [ Time Frame: 12 weeks ]
Patients need to rate 1) worst abdominal pain and 2)stool consistency everyday for 12 weeks after FMT. The proportion of composite responder over the 12 weeks will be assessed. A patient will be defined as a study composite responder if he or she meets the daily composite response criteria for at least 50% of days with diary entry during the interval from Weeks 1-12. A composite response must meet both of the following criteria on a given day:
  1. Pain response: worst abdominal pain scores in the past 24 hours <3, and;
  2. Stool consistency response: Bristol Stool Scale (BSS) score <5 or the absence of a bowel movement if accompanied by worst abdominal pain scores <3
To be an eligible responder, a patient must have a minimum of 60 days (i.e. >70%) of diary entries over the interval from Weeks 1-12 (Total 84 days). Any patient with fewer than 60 days of diary entry will be considered a non-responder.
Change History Complete list of historical versions of study NCT03125564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • The proportion of patients who had adequate relief of global IBS symptoms [ Time Frame: 12 weeks ]
    Adequate relief of global IBS symptoms
  • Assess the onset and duration of relief of IBS symptoms [ Time Frame: 12 weeks ]
    The onset and duration of relief of IBS symptoms
  • The proportion of patients who had improvement on worst abdominal bloating [ Time Frame: 12 weeks ]
    Proportion of patients who had improvement on worst abdominal bloating between the treatment arms.
  • Assess the onset and duration of worst abdominal bloating [ Time Frame: 12 weeks ]
    The onset and duration of worst abdominal bloating assessed by phone interview and on follow up visits.
  • The proportion of patients who had improvement of abdominal discomfort [ Time Frame: 12 weeks ]
    compare the difference in proportion of patients who had improvement on abdominal discomfort between the treatment arms.
  • Assess the onset and duration of abdominal discomfort [ Time Frame: 12 weeks ]
    The onset and duration of abdominal discomfort will be assessed through patient diary.
  • IBS-d global symptoms score [ Time Frame: 12 weeks ]
    The proportion of patients who had improvement on IBS-d global symptoms score
Original Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • The proportion of patients who had adequate relief of global IBS symptoms [ Time Frame: 12 weeks ]
    The proportion of patients who had adequate relief of global IBS symptoms will be determined from the response (yes or no) to the weekly question, "In regard to patient's IBS symptoms, as compared with the way patient felt before patient started study medication, have patient, in the past 7 days, had adequate relief of patient's IBS symptom?"
  • Assess the onset and duration of relief of IBS symptoms [ Time Frame: 12 weeks ]
    The onset and duration of relief of IBS symptoms will assessed by phone interview and on follow up visits.
  • The proportion of patients who had improvement on worst abdominal bloating [ Time Frame: 12 weeks ]
    Proportion of patients who had improvement on worst abdominal bloating between the treatment arms.
  • Assess the onset and duration of worst abdominal bloating [ Time Frame: 12 weeks ]
    The onset and duration of worst abdominal bloating assessed by phone interview and on follow up visits.
  • The proportion of patients who had improvement of abdominal discomfort [ Time Frame: 12 weeks ]
    compare the difference in proportion of patients who had improvement on abdominal discomfort between the treatment arms.
  • Assess the onset and duration of abdominal discomfort [ Time Frame: 12 weeks ]
    The onset and duration of abdominal discomfort will be assessed through patient diary.
  • IBS-d global symptoms score [ Time Frame: 12 weeks ]
    The proportion of patients who had improvement on IBS-d global symptoms score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment
Official Title  ICMJE A Randomised, Placebo-controlled Study on Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome With Fecal and Mucosal Microbiota Assessment
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Fecal Microbiota Transplantation
Intervention  ICMJE
  • Procedure: Fecal Microbiota Transplantation
    Fecal microbiota transplantation
  • Procedure: Sham
    Infusion of sham
  • Procedure: Fecal and Mucosal Microbiota Assessment
    To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation
Study Arms  ICMJE
  • Experimental: Fecal Microbiota Transplantation
    FMT infusion and Fecal and Mucosal Microbiota Assessment
    Interventions:
    • Procedure: Fecal Microbiota Transplantation
    • Procedure: Fecal and Mucosal Microbiota Assessment
  • Sham Comparator: Sham infusion
    Infusion with sham and Fecal and Mucosal Microbiota Assessment
    Interventions:
    • Procedure: Sham
    • Procedure: Fecal and Mucosal Microbiota Assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 19, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2019
Estimated Primary Completion Date January 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 two 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy Li +852 26373225 amyli@cuhk.edu.hk
Contact: Whitney Tang +852 35051519 whitneytang@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03125564
Other Study ID Numbers  ICMJE FMT-IBS study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Siew Chien NG, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Siew Ng, Prof. Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP