Last updated: February 16, 2024
Sponsor: Lallemand Health Solutions
Overall Status: Active - Recruiting
Phase
4
Condition
Colic
Hyponatremia
Lactose Intolerance
Treatment
Placebo
Probiotic formulation
Clinical Study ID
NCT05509725
C-005
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Experiencing symptoms of IBS-D
- 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
Exclusion Criteria:
- A history of inflammatory or immune-mediated gastrointestinal diseases
- Diagnosed with a co-existing organic gastrointestinal disease which can affect thestudy
- 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 exceptionof hernia repair or appendectomy
- Currently diagnosed with any mood- or anxiety-related disorder, major psychiatricillness, or participants with a history of suicidal ideation, or current suicidalideation,
- Regular use of anti-diarrhea medications and laxatives however occasional use ispermitted (≤ than once a month); if current use is > once per month a one month washout is needed,
- Unwilling to avoid the use of antidiarrheal or laxative medication on an "as-neededbasis" during the full length of the study,
- Pregnant, breast-feeding or planning on becoming pregnant.
Study Design
Total Participants: 162
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
August 11, 2022
Estimated Completion Date:
November 30, 2024
Study Description
Connect with a study center
Ege University Faculty of Medicine, Gastroenterology Department
İzmir, 35040
TurkeyActive - Recruiting
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