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Sponsor decision
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The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Test | Experimental |
| |
| 2 - Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 - Fermented dairy drink | Other | 1 - Fresh fermented dairy drink containing yoghurt ferments and probiotic strains consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of AAD | From Day 0 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of AAD | From Day 0 to Day 28 | |
| Time to event of AAD | From Day 0 to Day 28 | |
| Occurrence of Clostridium difficile Associated Diarrhea |
| Measure | Description | Time Frame |
|---|---|---|
| Clostridium difficile analysis in feces | from Day 0 to Day 28 | |
| Microbiota analysis in feces | from Day 0 to Day 42 | |
| Short-Chain Fatty Acids analysis in blood and feces |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Guillemard, PhD | Danone Research, Palaiseau, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation GmbH | Berlin | 10117 | Germany |
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| 2 - Acidified dairy drink | Other | 2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28) |
|
| From Day 0 to Day 28 |
| Time to event of Clostridium difficile Associated Diarrhea | From Day 0 to Day 28 |
| Duration of Clostridium difficile Associated Diarrhea | From Day 0 to Day 28 |
| Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting) | From Day 0 to Day 28 |
| Score of gastrointestinal symptoms | From Day 0 to Day 28 |
| from Day 0 to Day 42 |
| Calprotectin analysis in feces | from Day 0 to Day 42 |
| Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces | from Day 0 to Day 42 |