Efficacy and Safety of a Probiotic Formulation in Adults With Irritable Bowel Syndrome With Diarrhea (IBS-D)
NCT ID: NCT05509725
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
162 participants
INTERVENTIONAL
2022-08-11
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Intervention
Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks.
Probiotic formulation
Participants will be asked to take 2 doses daily
Control
Participants in this group will be randomized to receive placebo for the following 8 weeks.
Placebo
Participants will be asked to take 2 doses daily
Interventions
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Probiotic formulation
Participants will be asked to take 2 doses daily
Placebo
Participants will be asked to take 2 doses daily
Eligibility Criteria
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Inclusion Criteria
* Having a diagnosis of IBS-D based on Rome IV criteria
* Participants with symptom onset at least 6 months before diagnosis
* Having a normal colonoscopy result in their medical file
Exclusion Criteria
* Diagnosed with a co-existing organic gastrointestinal disease which can affect the study
* Currently undergoing a treatment for other severe conditions such as coronary disease, neurological disorder, kidney or liver disease,
* Currently diagnosed with an eating disorder,
* Having undergone any abdominal surgery including cholecystectomy, with the exception of hernia repair or appendectomy
* Currently diagnosed with any mood- or anxiety-related disorder, major psychiatric illness, or participants with a history of suicidal ideation, or current suicidal ideation,
* Regular use of anti-diarrhea medications and laxatives however occasional use is permitted (≤ than once a month); if current use is \> once per month a one month wash out is needed,
* Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-needed basis" during the full length of the study,
* Pregnant, breast-feeding or planning on becoming pregnant.
18 Years
75 Years
ALL
Yes
Sponsors
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Lallemand Health Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Serhat Bor, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ege University
Locations
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Ege University Faculty of Medicine, Gastroenterology Department
Izmir, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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C-005
Identifier Type: -
Identifier Source: org_study_id
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