NCT02746198

Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)

A Randomized Double-blind Placebo-controlled Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD) in Patients With Helicobacter Pylori Eradication Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Clinical Research Center Kiel GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Helicobacter p. positive subjects aged ≥18 years with an indication for Helicobacter pylori (Hp) eradication recommended by a gastroenterologist should be included in the study. Subjects should be willing to consume 2 servings of the study product per day for 6 weeks, and to undergo an Hp eradication therapy for 14 days starting with the consumption period.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
OTHER	probiotic dairy drink
OTHER	acidified milk

Timeline

• Start date: 2016-01-22
• Primary completion: 2016-12-23
• Completion: 2017-04-26
• First posted: 2016-04-21
• Last updated: 2021-02-08

Locations

1 site across 1 country: Germany