Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and… (NCT02900196) | Clinical Trial Compass
TerminatedNot Applicable
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
Stopped: Sponsor decision
Germany136 participantsStarted 2016-09-16
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 …