Antibiotic-Associated Diarrhea
Conditions
Keywords
Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori
Brief summary
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.
Interventions
OTHER1 - Fermented dairy drink
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)
OTHER2 - Acidified dairy drink
2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of AAD | From Day 0 to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Duration of AAD | From Day 0 to Day 28 |
Other
| Measure | Time frame |
|---|---|
| Short-Chain Fatty Acids analysis in blood and feces | 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 |
| Microbiota analysis in feces | from Day 0 to Day 42 |
| Clostridium difficile analysis in feces | from Day 0 to Day 28 |
Countries
Germany
Outcome results
None listed