Status:
UNKNOWN
Intestinal Permeability and Intestinal Microbiota in Irritable Bowel Syndrome
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Irritable Bowel Syndrome With Diarrhea
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
Patients with diarrhea-predominant irritable bowel syndrome (IBS) and functional dyspepsia (FD) were examined and received treatment in the study. Severity of complaints and quality of life patients w...
Detailed Description
The study included 60 patients with an established diagnosis IBS and FD. Patients were randomized in toone of three groups. Patients in group 1 received Trimedat (trimebutine, marketing authorization ...
Eligibility Criteria
Inclusion
- Signed informed consent
- A man or woman aged 18-59.
- For women of childbearing age: mandatory use of contraceptive methods.
- Confirmed diagnosis of IBS-D and functional dyspepsia by clinical, instrumental and blood chemistry findings (according to the Clinical Guidelines of the Russian Gastroenterological Association and the Russian Association of Coloproctologists (2016)
- Absence of Helicobacter Pylori infection according to the urea breath test in the past 6 months before inclusion.
- Ability to understand and willingness to comply with all protocol details.
Exclusion
- Prematurely discontinuation of the consumption of tested drugs/placebo;
- Started taking antibiotics, other probiotics, or prebiotics during the follow-up period;
- Refusal to participate during the follow-up period, including refusal to come for re-examination 2 months after inclusion;
- Cancer or inflammatory bowel disease diagnosis during the follow-up period.
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05379036
Start Date
June 23 2021
End Date
May 31 2022
Last Update
May 18 2022
Active Locations (1)
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1
Elena Poluektova
Moscow, Russia