Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)
NCT02746198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2021-02-08
Summary
The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.
Conditions
- Antibiotic-associated Diarrhea
Interventions
- OTHER
-
probiotic dairy drink
- OTHER
-
acidified milk
Sponsors & Collaborators
-
Yakult Honsha Co., LTD
collaborator INDUSTRY -
Clinical Research Center Kiel GmbH
lead OTHER
Principal Investigators
-
Chiyuki Kajita · Yakult Europe BV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-22
- Primary Completion
- 2016-12-23
- Completion
- 2017-04-26
Countries
- Germany
Study Locations
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