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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Antibiotic-associated Diarrhea
- Sponsor
- Clinical Research Center Kiel GmbH
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- Occurrence of antibiotic-associated diarrhea (AAD)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals, both genders, aged ≥ 18 y
- •Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
- •Willingness to undergo the Helicobacter p. eradication therapy
- •Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
- •Written informed consent
Exclusion Criteria
- •Subjects currently enrolled in another interventional trial
- •subjects having finished another interventional trial within the last 4 weeks before inclusion
- •incapacity to comply with the study protocol
- •allergy or hypersensitivity to any component of the test product (allergy against milk protein)
- •allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
- •acute GIT infections
- •chronic inflammatory bowel diseases (IBD)
- •irritable bowel syndrome (IBS)
- •any episode of diarrhea according to WHO criteria during the last 4 weeks before inclusion
- •history of lactose intolerance
Outcomes
Primary Outcomes
Occurrence of antibiotic-associated diarrhea (AAD)
Time Frame: 6 weeks
Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO
Secondary Outcomes
- Cumulative sverity of antibiotic-associated diarrhea (AAD)(6 weeks)
- Gastrointestinal Symptom Rating Scale(6 weeks)
- Cumulated duration of antibiotic-associated diarrhea (AAD)(6 weeks)