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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02900196
Other study ID # NU372
Secondary ID
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
Health authority
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

Study Design


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
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