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

NCT ID: NCT02900196

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-16
• Study Completion Date: 2017-08-10

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.

Conditions

Antibiotic-Associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

1 - Test

Group Type: EXPERIMENTAL

1 - Fermented dairy drink

Intervention Type: OTHER

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)

2 - Placebo

Group Type: PLACEBO_COMPARATOR

2 - Acidified dairy drink

Intervention Type: OTHER

2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)

Interventions

1 - 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)

Intervention Type: OTHER

2 - 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Guillemard, PhD

Role: STUDY_CHAIR

Danone Research, Palaiseau, France

Locations

Charité Research Organisation GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

NU372

Identifier Type: -

Identifier Source: org_study_id