IBS - Irritable Bowel Syndrome
Conditions
Keywords
IBS-D, Probiotics
Brief summary
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.
Detailed description
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.
Interventions
Participants will be asked to take 2 doses daily
DRUGPlacebo
Participants will be asked to take 2 doses daily
Sponsors
Lallemand Health Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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 criteria
* A history of inflammatory or immune-mediated gastrointestinal diseases * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdominal Pain | 8 weeks | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) |
| Change in Defecation consistency | 8 weeks | Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abnormal defecation consistency | up to 10 weeks | Change in abnormal defecation consistency using the Bristol Stool Scale (BSS) from Type 1 (severe constipation) to Type 7 (severe diarrhea) |
| Stool frequency | up to 10 weeks | Measured as the average number of stools per week |
| Perceived Stress | 8 weeks | Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress) |
| Change in Irritable Bowel Syndrome Symptom Severity Scores | 8 weeks | Using the The irritable bowel severity scoring system (IBS-SSS) |
| Abdominal discomfort | up to 10 weeks | Using questionnaire in participants diary |
| Change Abdominal pain intensity | up to 10 weeks | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactBurcu Sume
Outcome results
None listed