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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900196
Recruitment Status : Terminated (Sponsor decision)
First Posted : September 14, 2016
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Danone Research

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.

Condition or disease Intervention/treatment Phase
Antibiotic-Associated Diarrhea Other: 1 - Fermented dairy drink Other: 2 - Acidified dairy drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 16, 2016
Actual Primary Completion Date : August 10, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

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)




Primary Outcome Measures :
  1. Occurrence of AAD [ Time Frame: From Day 0 to Day 28 ]

Secondary Outcome Measures :
  1. Duration of AAD [ Time Frame: From Day 0 to Day 28 ]
  2. Time to event of AAD [ Time Frame: From Day 0 to Day 28 ]
  3. Occurrence of Clostridium difficile Associated Diarrhea [ Time Frame: From Day 0 to Day 28 ]
  4. Time to event of Clostridium difficile Associated Diarrhea [ Time Frame: From Day 0 to Day 28 ]
  5. Duration of Clostridium difficile Associated Diarrhea [ Time Frame: From Day 0 to Day 28 ]
  6. Number of days with main GI symptoms (diarrhea, abdominal pain, bloating, nausea, vomiting) [ Time Frame: From Day 0 to Day 28 ]
  7. Score of gastrointestinal symptoms [ Time Frame: From Day 0 to Day 28 ]

Other Outcome Measures:
  1. Clostridium difficile analysis in feces [ Time Frame: from Day 0 to Day 28 ]
  2. Microbiota analysis in feces [ Time Frame: from Day 0 to Day 42 ]
  3. Short-Chain Fatty Acids analysis in blood and feces [ Time Frame: from Day 0 to Day 42 ]
  4. Calprotectin analysis in feces [ Time Frame: from Day 0 to Day 42 ]
  5. Microbiological assessment of probiotic bacterial strains (of study product) in subjects feces [ Time Frame: from Day 0 to Day 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900196


Locations
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Germany
Charité Research Organisation GmbH
Berlin, Germany, 10117
Sponsors and Collaborators
Danone Research
Investigators
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Study Chair: Eric Guillemard, PhD Danone Research, Palaiseau, France

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Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT02900196    
Other Study ID Numbers: NU372
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Keywords provided by Danone Research:
Probiotics
Antibiotic Associated Diarrhea
Gastro-Intestinal disorders
Helicobacter pylori
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents