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Slow recruitment, high drop-out
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| Name | Class |
|---|---|
| Almarai | UNKNOWN |
| Clinart International | INDUSTRY |
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A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vetal Laban active | Active Comparator | Vetal Laban with L. acidophilus |
|
| Placebo | Placebo Comparator | Vetal Laban -like product without L. acidophilus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vetal Laban active | Dietary Supplement | Dairy product with probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in functional bowel symptoms | Validated questionnaire | week 0, 4, 8, 12 and 16 |
| Measure | Description | Time Frame |
|---|---|---|
| change in adequate relief of bowel symptoms | Weekly question | weekly from week 4 to week 12 |
| change in stool defecation frequency | Validated scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdullah Aljahdali, MD | King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia | Principal Investigator |
| Arthur C Ouwehand, PhD | Danisco Sweeteners Ltd. | Study Chair |
| Anna H Lyra, PhD | Danisco Sweeteners Ltd. | Study Director |
| Suzanne Alodaib, MSc | Almarai Company, Saudi Arabia | Study Director |
| Abed Allehibi, Dr | King Fahd Medical City | Principal Investigator |
| Othman Al-Harbi, Dr | King Khalid University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Fahd Medical City | Riyadh | Saudi Arabia | ||||
| King Khalid University Hospital |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| Placebo | Dietary Supplement | Dairy product without probiotic |
|
|
| week 0, 4, 8, 12 and 16 |
| change in stool microbiota | molecular analyses | week 4, 8, 12 and 16 |
| change in prevalence of adverse events | Recording of adverse and serious adverse events | continuous from week 0 to 16 |
| change in stool consistency | Validated scale | week 0, 4, 8, 12 and 16 |
| Riyadh |
| Saudi Arabia |
| D004066 | Digestive System Diseases |