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

Primary Purpose

Antibiotic-Associated Diarrhea

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
1 - Fermented dairy drink
2 - Acidified dairy drink
Sponsored by
Danone Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic-Associated Diarrhea focused on measuring Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité Research Organisation GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 - Test

2 - Placebo

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of AAD

Secondary Outcome Measures

Duration of AAD
Time to event of AAD
Occurrence of Clostridium difficile Associated Diarrhea
Time to event of Clostridium difficile Associated Diarrhea
Duration of Clostridium difficile Associated Diarrhea
Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)
Score of gastrointestinal symptoms

Full Information

First Posted
September 2, 2016
Last Updated
February 5, 2018
Sponsor
Danone Research
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1. Study Identification

Unique Protocol Identification Number
NCT02900196
Brief Title
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
September 16, 2016 (undefined)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea
Keywords
Probiotics, Antibiotic Associated Diarrhea, Gastro-Intestinal disorders, Helicobacter pylori

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Test
Arm Type
Experimental
Arm Title
2 - Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
1 - Fermented dairy drink
Intervention Description
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
Intervention Name(s)
2 - Acidified dairy drink
Intervention Description
2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
Primary Outcome Measure Information:
Title
Occurrence of AAD
Time Frame
From Day 0 to Day 28
Secondary Outcome Measure Information:
Title
Duration of AAD
Time Frame
From Day 0 to Day 28
Title
Time to event of AAD
Time Frame
From Day 0 to Day 28
Title
Occurrence of Clostridium difficile Associated Diarrhea
Time Frame
From Day 0 to Day 28
Title
Time to event of Clostridium difficile Associated Diarrhea
Time Frame
From Day 0 to Day 28
Title
Duration of Clostridium difficile Associated Diarrhea
Time Frame
From Day 0 to Day 28
Title
Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting)
Time Frame
From Day 0 to Day 28
Title
Score of gastrointestinal symptoms
Time Frame
From Day 0 to Day 28
Other Pre-specified Outcome Measures:
Title
Clostridium difficile analysis in feces
Time Frame
from Day 0 to Day 28
Title
Microbiota analysis in feces
Time Frame
from Day 0 to Day 42
Title
Short-Chain Fatty Acids analysis in blood and feces
Time Frame
from Day 0 to Day 42
Title
Calprotectin analysis in feces
Time Frame
from Day 0 to Day 42
Title
Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces
Time Frame
from Day 0 to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Guillemard, PhD
Organizational Affiliation
Danone Research, Palaiseau, France
Official's Role
Study Chair
Facility Information:
Facility Name
Charité Research Organisation GmbH
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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

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