Viewing Study NCT02746198



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Last Modification Date: 2024-10-26 @ 12:00 PM
Study NCT ID: NCT02746198
Status: COMPLETED
Last Update Posted: 2021-02-08
First Post: 2016-04-12

Brief Title: Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea AAD
Sponsor: Clinical Research Center Kiel GmbH
Organization: Clinical Research Center Kiel GmbH

Study Overview

Official Title: 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
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None