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

Not Applicable

Terminated

• Conditions: Antibiotic-Associated Diarrhea
• Interventions: Other: 1 - Fermented dairy drink; Other: 2 - Acidified dairy drink

• Registration Number: NCT02900196
• Lead Sponsor: Danone Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Study Start: 2016-09-16
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - Test	1 - Fermented dairy drink	-
2 - Placebo	2 - Acidified dairy drink	-

Primary Outcome Measures

Name	Time	Method
Occurrence of AAD	From Day 0 to Day 28

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Charité Research Organisation GmbH; 🇩🇪 Berlin, Germany