Clinical trial NCT02900196: Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Antibiotic-Associated Diarrhea
Keywords: Probiotics
Antibiotic Associated Diarrhea
Gastro-Intestinal disorders
Helicobacter pylori
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of AAD
timeFrame: From Day 0 to Day 28
Secondary outcomes:
measure: Duration of AAD
timeFrame: From Day 0 to Day 28
measure: Time to event of AAD
timeFrame: From Day 0 to Day 28
measure: Occurrence of Clostridium difficile Associated Diarrhea
timeFrame: From Day 0 to Day 28
measure: Time to event of Clostridium difficile Associated Diarrhea
timeFrame: From Day 0 to Day 28
measure: Duration of Clostridium difficile Associated Diarrhea
timeFrame: From Day 0 to Day 28
measure: Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)
timeFrame: From Day 0 to Day 28
measure: Score of gastrointestinal symptoms
timeFrame: From Day 0 to Day 28
Other outcomes:
measure: Clostridium difficile analysis in feces
timeFrame: from Day 0 to Day 28
measure: Microbiota analysis in feces
timeFrame: from Day 0 to Day 42
measure: Short-Chain Fatty Acids analysis in blood and feces
timeFrame: from Day 0 to Day 42
measure: Calprotectin analysis in feces
timeFrame: from Day 0 to Day 42
measure: Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces
timeFrame: from Day 0 to Day 42
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
affiliation: Danone Research, Palaiseau, France
name: Eric Guillemard, PhD
role: STUDY_CHAIR
References: