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

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.

Study Overview

• Status: Terminated
• Conditions: Antibiotic-Associated Diarrhea
• Intervention / Treatment: Other: 1 - Fermented dairy drink; Other: 2 - Acidified dairy drink

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité Research Organisation GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 - Test	Other: 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)
Placebo Comparator: 2 - Placebo	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of AAD	From Day 0 to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Clostridium difficile analysis in feces	from Day 0 to Day 28
Microbiota analysis in feces	from Day 0 to Day 42
Short-Chain Fatty Acids analysis in blood and feces	from Day 0 to Day 42
Calprotectin analysis in feces	from Day 0 to Day 42
Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces	from Day 0 to Day 42

Collaborators and Investigators

• Sponsor: Danone Research
• Investigators: Study Chair: Eric Guillemard, PhD, Danone Research, Palaiseau, France

Study record dates

Study Major Dates

• Study Start: September 16, 2016
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Probiotics; Helicobacter pylori; Antibiotic Associated Diarrhea; Gastro-Intestinal disorders
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: NU372