Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders

Study Overview
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Brief Summary
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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.

Conditions
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Antibiotic-Associated Diarrhea

Intervention / Treatment
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* Other: 1 - Fermented dairy drink
* Other: 2 - Acidified dairy drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have read and signed the Study Informed Consent Form Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori Exclusion Criteria: Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial Subject who have a history of alcohol abuse Subjects having diarrhea within the preceding 4-weeks Subjects with severe life-threatening illness, severe evolutive or chronic pathology Immune-suppressed subjects Subjects with benign peptic ulcer or pre-malignant or malignant lesion Subjects presenting with an infection of the gastrointestinal tract Subjects with any past severe gastro-intestinal or metabolic pathology Subjects with history of Helicobacter pylori eradication therapy Subjects with history of cardiac or renal clinically significant disease Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori Subjects taking treatments likely to interfere with the evaluation of study parameters. Subjects with allergy or hypersensitivity to any component of the study products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Test<br> | Other: 1 - Fermented dairy drink<br>* 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)<br>|
| Placebo Comparator: 2 - Placebo<br> | Other: 2 - Acidified dairy drink<br>* 2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of AAD |  | From Day 0 to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori