Impact of a multispecies probiotic on the intestinal microbiome during antibiotic treatment
- Conditions
- Disruption of intestinal microbiota due to antibiotic use
- Registration Number
- DRKS00014622
- Lead Sponsor
- nutrimmun GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 84
Main inclusion criteria: positive diagnosis of H. pylori infection based on results of gastroscopy / histology., Indication of Helicobacter eradication according to standard triple therapy (French) as a primary treatment for 7 days (1-0-1), men and women (at least 30% of each gender), age: 18 – 70 years, BMI: 18.5 – 30, written informed consent
main exclusion Criteria:
Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. Colon-cancer, rectum cancer, pancreatitis), immune suppressed patients,Diabetes mellitus, regular intake of probiotics 4 weeks prior to and during the study, use of antibiotics (oral or i.v.) 3 months prior to study start, participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study, women: known pregnancy, breast feeding or intention to become pregnant during the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method diversity of intestinal microbiome after H. pylori eradication
- Secondary Outcome Measures
Name Time Method i.a. composition of interinal microbiome (genus, family, species) after H. pylori eradication, after probiotic intake and 6 weeks after study start (follow up)