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First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1=BOW_01 | Experimental | 1= Fermented Milk Product containing Probiotics |
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| 2=BOW_01 + fiber C | Experimental | 2= Fermented Milk Product containing Probiotics + Fibers C |
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| 3 =BOW_01 + fiber W | Experimental | 3= Fermented Milk Product containing Probiotics + Fibers W |
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| 4 = Control | Placebo Comparator | 4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fermented milk product containing Probiotics | Other | 2 pots/day during 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks. | Baseline and after 4 weeks. | |
| Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks. | Baseline and after 4 weeks. | |
| Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week. | Baseline and during the 4th week. | |
| Change in fecal bulk (stool weight) at baseline and after 4 weeks. | Baseline and after 4 weeks. | |
| Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks. | Baseline and after 2 and 4 weeks. Validated questionnaire. | |
| Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks. | Baseline and after 2 and 4 weeks. Validated questionnaire. | |
| Study product satisfaction by questionnaire after 2 and 4 weeks. | after 2 and 4 weeks. | |
| Adverse events in the week before baseline, at baseline, week 3, 4 and 5. | Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study) |
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Main eligibility criteria (non-exhaustive list) are defined as:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | Ireland |
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| Fermented Milk Product containing Probiotics + Fibers C |
| Other |
2 pots/day during 28 days |
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| Fermented Milk Product containing Probiotics + Fibers W | Other | 2 pots/day during 28 days |
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| Non fermented Milk Product | Other | 2 pots/day during 28 days |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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