The purpose of the study is to monitor safety and to evaluate the efficacy of a probiotic formulation on abdominal pain, abnormal defecation, comorbid mood disorders (anxiety and depression) as well as general quality of life in adults with IBS-D.
To monitor safety and to evaluate the efficacy of a probiotic formulation on severity of gastrointestinal symptoms (abdominal pain, abnormal defecation), anxiety, depression and quality of life in adult participants with IBS-D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
162
Participants will be asked to take 2 doses daily
Participants will be asked to take 2 doses daily
Ege University Faculty of Medicine, Gastroenterology Department
Izmir, Turkey (Türkiye)
RECRUITINGChange in Abdominal Pain
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Time frame: 8 weeks
Change in Defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Time frame: 8 weeks
Change Abdominal pain intensity
Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible)
Time frame: up to 10 weeks
Abnormal defecation consistency
Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea)
Time frame: up to 10 weeks
Stool frequency
Measured as the average number of stools per week
Time frame: up to 10 weeks
Abdominal discomfort
Using questionnaire in participants diary
Time frame: up to 10 weeks
Perceived Stress
Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress)
Time frame: 8 weeks
Change in Irritable Bowel Syndrome Symptom Severity Scores
Using the The irritable bowel severity scoring system (IBS-SSS)
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Time frame: 8 weeks