Status:
COMPLETED
Faecal Microbiota Transplantation in Irritable Bowel Syndrome
Lead Sponsor:
Thomayer University Hospital
Collaborating Sponsors:
Charles University, Czech Republic
Conditions:
Irritable Bowel Syndrome With Diarrhea
Irritable Bowel Syndrome Mixed
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that ...
Detailed Description
Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will unde...
Eligibility Criteria
Inclusion
- Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria
Exclusion
- The use of antibiotics within one month prior to faecal microbiota transplantation
- The use of probiotics within one month prior to faecal microbiota transplantation
- History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)
- Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)
- HIV infection or other active infection
- Renal or hepatic disease (both defined by biochemistry workup)
- Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications
- Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score \> 15
- Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score \> 10
- Current pregnancy and lactation
Key Trial Info
Start Date :
June 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04899869
Start Date
June 17 2021
End Date
April 29 2024
Last Update
May 24 2024
Active Locations (1)
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1
Thomayer University Hospital
Prague, Czechia, 14059