Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants in this group will be randomized to receive probiotic formulation for the following 8 weeks. |
|
| Control | Placebo Comparator | Participants in this group will be randomized to receive placebo for the following 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic formulation | Drug | Participants will be asked to take 2 doses daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Pain | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) | 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change Abdominal pain intensity | Change in abdominal pain intensity using Visual Analog Scale (VAS) from 0 (no symptom) to 10 (worst possible) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Burcu Sume | Contact | +90 312 479 88 75 | burcus@croturk.com |
| Name | Affiliation | Role |
|---|---|---|
| Serhat Bor, Prof. Dr. | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine, Gastroenterology Department | Recruiting | Izmir | 35040 | Turkey (Türkiye) |
After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Participants will be asked to take 2 doses daily |
|
| up to 10 weeks |
| Stool frequency | Measured as the average number of stools per week | up to 10 weeks |
| Abdominal discomfort | Using questionnaire in participants diary | up to 10 weeks |
| Perceived Stress | Using the Perceived Stress Scale (PSS) grading from 0 (low stress) to 40 (high perceived stress) | 8 weeks |
| Change in Irritable Bowel Syndrome Symptom Severity Scores | Using the The irritable bowel severity scoring system (IBS-SSS) | 8 weeks |
| D004066 | Digestive System Diseases |