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

Antibiotic-Associated Diarrhea Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02900196
• Other study ID #: NU372
• Status: Terminated
• Phase: N/A
• First received: September 2, 2016
• Last updated: February 5, 2018
• Start date: September 16, 2016
• Est. completion date: August 10, 2017

Study information

• Verified date: February 2018
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 136
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic-Associated Diarrhea
• Diarrhea
• Digestive System Diseases
• Gastrointestinal Diseases
• Intestinal Diseases

Intervention

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)
• 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)

Locations

Country	Name	City	State
Germany	Charité Research Organisation GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clostridium difficile analysis in feces		from Day 0 to Day 28
Other	Microbiota analysis in feces		from Day 0 to Day 42
Other	Short-Chain Fatty Acids analysis in blood and feces		from Day 0 to Day 42
Other	Calprotectin analysis in feces		from Day 0 to Day 42
Other	Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces		from Day 0 to Day 42
Primary	Occurrence of AAD		From Day 0 to Day 28
Secondary	Duration of AAD		From Day 0 to Day 28
Secondary	Time to event of AAD		From Day 0 to Day 28
Secondary	Occurrence of Clostridium difficile Associated Diarrhea		From Day 0 to Day 28
Secondary	Time to event of Clostridium difficile Associated Diarrhea		From Day 0 to Day 28
Secondary	Duration of Clostridium difficile Associated Diarrhea		From Day 0 to Day 28
Secondary	Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)		From Day 0 to Day 28
Secondary	Score of gastrointestinal symptoms		From Day 0 to Day 28