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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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Hypothesis:
In previous preliminary study we have shown that daily consumption of a probiotic yogurt drink containing probiotic bacteria (Bifidobacterium lactis Bb12) and inulin significantly accelerate colonic transit time in non-patients population with functional bowel symptoms. In this study we investigate the physiologic effect(s) of yogurt with the same bacteria and inulin on gastrointestinal function by assessing its effect on the whole gut and segmental transit time using SmartPillâ„¢ - a recently introduced device of measuring intestinal transit time. The proposed study will provide additional information on the effect on the whole gut transit as well as on other segments of the GI tract (stomach and small bowel). Assessment of transit time in the proposed study will be done following 10 to 14 days of the probiotic yogurt consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yogurt with probiotics and inulin | Active Comparator | A probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving). |
|
| Placebo | Placebo Comparator | Acidified dairy snack without yogurt cultures, probiotic or inulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A probiotic yogurt with inulin | Other | A 4 oz. cup with a probiotic yogurt containing Streptococcus thermophilus and Lactobacillus bulgaricus (at least 1x10^8 cfu/g); the probiotic bacteria Bifidobacterium lactis (Bb12) (5x10^7 cfu/g; 5x10^9 cfu/serving) and Inulin (3gr/serving), once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measures will be the whole gut (WGTT) and colonic transit time (CTT) as assessed by SmartPillâ„¢ | 10-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome measures (a) Stool frequency (b) Stool consistency (c) Gastric emptying and small bowel transit time | 10-28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamar Ringel-Kulka, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-CH Program of Digestive Health | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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|
| Acidified dairy snack | Other | A 4 oz. cup of acidified dairy snack, once daily. |
|
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |