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Trial record 3 of 3 for:    17631127 [PUBMED-IDS]

FMT for Patients With IBS With Fecal and Mucosal Microbiota Assessment

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ClinicalTrials.gov Identifier: NCT03125564
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

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 (1). It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating (2), 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 (10). In a small retrospective study using FMT to treat 13 IBS patients, 70% of patients had symptomatic improvement particularly those with abdominal pain, dyspepsia, bloating and flatus. Nearly half of the patients achieved improvement in overall well-being. The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS. The investigators will assess the fecal and mucosal microbiota before and after FMT. Patients will be randomized to either FMT or placebo over a 12 weeks period.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Fecal Microbiota Transplantation Procedure: Fecal Microbiota Transplantation Procedure: Sham Procedure: Fecal and Mucosal Microbiota Assessment Not Applicable

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 (1). It is characterised by abdominal pain, irregular bowel habits, altered stool consistencies and bloating (2), 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 (3).

Accumulating data suggest that the intestinal microbiota play an important role in the pathophysiology of IBS (4;5). This is derived from early observation that post-infectious IBS developed in a subgroup of patients following a bout of gastroenteritis (6;7). Several studies have shown that the fecal microbiota was altered in IBS (4) and IBS symptoms can be improved by therapeutic interventions that target the microbiota including antibiotics, probiotics and prebiotics (8). Rifaximin, an oral, non-systemic broad spectrum antibiotics has also been shown to provide significant relief in IBS symptoms in a randomized controlled trial (9).

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 (10). In a small retrospective study using FMT to treat 13 IBS patients, 70% of patients had symptomatic improvement particularly those with abdominal pain, dyspepsia, bloating and flatus. Nearly half of the patients achieved improvement in overall well-being. This study showed encouraging results and call for a prospective randomized study to further evaluate the role of FMT in IBS (11;12). Furthermore, the mechanism of FMT in IBS is not completely clear, and limited data are available on the effects of FMT on the microbiota post FMT. The experimental tools required for in depth analysis of the intestinal microbiota are now becoming available.

The investigators propose a randomised, placebo-controlled trial of FMT in patients with IBS. The investigators will assess the fecal and mucosal microbiota before and after FMT.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-controlled Study on Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome With Fecal and Mucosal Microbiota Assessment
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : January 2, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fecal Microbiota Transplantation
FMT infusion at randomization and week 4. Fecal and mucosal microbiota assessment before and after infusion.
Procedure: Fecal Microbiota Transplantation
Feces from healthy donor will be diluted with sterile saline, blended and filtered. Supernatant will be infused to subject.
Procedure: Fecal and Mucosal Microbiota Assessment
To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation
Sham Comparator: Sham infusion
Infusion with saline water at randomization and week 4. Fecal and mucosal microbiota assessment before and after infusion.
Procedure: Sham
Infusion of saline water.
Procedure: Fecal and Mucosal Microbiota Assessment
To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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?"

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. IBS-d global symptoms score [ Time Frame: 12 weeks ]
    The proportion of patients who had improvement on IBS-d global symptoms score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 two years of recruitment. If no colonoscopy was done within two years of recruitment, an early colonoscopy will be arranged
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125564


Contacts
Contact: Amy Li +852 26373225 amyli@cuhk.edu.hk
Contact: Whitney Tang +852 35051519 whitneytang@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Sha Tin, Hong Kong, 000000
Contact: Siew Chien Ng, PhD    35053996    siewchienng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Siew Ng, Prof. Chinese University of Hong Kong

Publications:

Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03125564     History of Changes
Other Study ID Numbers: FMT-IBS study
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases