Status:
COMPLETED
Fecal Microbiota Transplantation in Irritable Bowel Syndrome With Bloating
Lead Sponsor:
University Hospital, Ghent
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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)
- 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
- 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)
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02299973
Start Date
October 1 2014
End Date
December 1 2017
Last Update
December 8 2017
Active Locations (1)
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1
Ghent University Hospital
Ghent, Belgium, 9000