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

Danone

Status: Terminated

Conditions: Antibiotic-Associated Diarrhea

Treatments: Other: 1 - Fermented dairy drink; Other: 2 - Acidified dairy drink

Study type: Interventional

Funder types: Industry

Identifiers

NCT02900196

NU372

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 2 patient groups, including a placebo group

1 - Test

Experimental group

Treatment:

Other: 1 - Fermented dairy drink

2 - Placebo

Placebo Comparator group

Treatment:

Other: 2 - Acidified dairy drink