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Trial record 2 of 3 for:    17631127 [PUBMED-IDS]

Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating

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ClinicalTrials.gov Identifier: NCT02299973
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Gastro-enterologie, University Hospital, Ghent

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Procedure: FMT with donor stool Procedure: FMT with own stool Not Applicable

Detailed Description:

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. Donors for this study will be recruited from a healthy donor pool who will donate stool after clearance of a strict inclusion protocol which will assess the presence of any infectious diseases. Stool will be frozen following the protocol described in Hamilton et al 2012. Patients will deliver a stool portion that will be frozen as well.

At time of FMT, patients will be randomised in a double blinded fashion to the treatment arm (healthy donor stool) or placebo arm (own stool). Transplantation will be preformed by means of a colonoscopy with deliverance in the right colon and ileum.

Following FMT patients will be followed clinically with questionnaires and regular visits to the clinic. Stool samples will be collected on a regular basis for microbiome analysis.

At the end of the study, patients from the placebo-group will be given the opportunity to be transplanted with healthy donor stool if necessary. Follow-up will continu for a total duration of one year.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating: a Double Blind, Placebo Controlled Randomised Clinical Trial
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Placebo Comparator: Placebo group (FMT with own stool)
Fecal microbiota transplantation with patient's own stool
Procedure: FMT with own stool
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
Other Name: Fecal microbiota transplantation with own stool

Experimental: Treatment group (FMT with donor stool)
Fecal microbiota transplantation with healthy donor stool
Procedure: FMT with donor stool
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
Other Name: Fecal microbiota transplantation with healthy donor stool




Primary Outcome Measures :
  1. Reduction of overall IBS symptoms (Key question 1) [ Time Frame: 3 months after FMT ]
    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?)

  2. Reduction of abdominal bloating (Key question 2) [ Time Frame: 3 months after FMT ]
    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?)


Secondary Outcome Measures :
  1. Changes in fecal microbiome composition (Illumina sequencing) [ Time Frame: 3 months after FMT ]
    Before and after FMT stool samples will be collected on a regular basis to assess the changes in microbiome changes (Illumina sequencing).

  2. Changes in IBS symptom scores at three months after FMT [ Time Frame: 3 months after FMT ]
    IBS symptoms will be assessed by use of a daily symptom diary which will measure abdominal discomfort, pain, bloating, flatulence, stool frequency, stool consistency and urgency

  3. Changes in IBS symptom scores at six months post FMT [ Time Frame: 6 months ]
    Key questions and symptom diary scores will be repeated 6 months after FMT to assess the duration of effects

  4. Changes in IBS symtom scores at 9 months post FMT [ Time Frame: 9 months ]
    Key questions and symptom diary scores will be repeated 9 months after FMT to assess the duration of effects

  5. Changes in IBS symptom scores at 1 year post FMT [ Time Frame: 1 year ]
    Key questions and symptom diary scores will be repeated 1 year after FMT to assess the duration of effects

  6. Composition of mucosal-adherent microbiota (Illumina sequencing) [ Time Frame: 3 months ]
    Composition of mucosal-adherent microbiota will be assessed by Illumina sequencing. Biopsies will be taken at time of FMT and snap frozen for further analysis.

  7. Changes of IBS symptom scores in patients who undergo an off-trial FMT [ Time Frame: 3 months ]
    After unblinding patients who were included in the placebo group, will be offered the possibility of FMT. Effects in these patients will be followed by IBS symptoms scores and answers to key questions at 3 months post FMT



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  1. Inclusion Criteria for patients:

    • 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)
  2. Exclusion Criteria for patients:

    • 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
  3. Inclusion criteria for donors

    • 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)
  4. Exclusion criteria for donors

    • presence of gastrointestinal symptoms
    • gastro-intestinal or other important comorbidity
    • obesity or metabolic syndrome
    • history of malignancy both gastrointestinal or systemic
    • presence of known colon polyps
    • recent placing of piercings/tattoos
    • sexual risk behaviour
    • antimicrobial therapy 3 months prior to donation

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): NCT02299973


Locations
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Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Danny De Looze, MD, PhD University Hospital, Ghent

Publications:
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Responsible Party: Gastro-enterologie, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02299973     History of Changes
Other Study ID Numbers: UGent_Gastro_001
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Keywords provided by Gastro-enterologie, University Hospital, Ghent:
irritable bowel syndrome
fecal microbiota transplantation
bloating
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases