Disruption of intestinal microbiota due to antibiotic use
Conditions
Interventions
Group 1: Intake of study product (1 sachet with 4g in 200 mL water) once daily before lunch for 3 weeks. Therefrom 7 days in parallel to triple therapy and additionally until 2 weeks after stopping er
Sponsors
nutrimmun GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| diversity of intestinal microbiome after H. pylori eradication | — |
Secondary
| Measure | Time frame |
|---|---|
| i.a. composition of interinal microbiome (genus, family, species) after H. pylori eradication, after probiotic intake and 6 weeks after study start (follow up) | — |
Countries
Germany
Contacts
Public ContactAndreas Lügering
MVZ Portal 10 Zentrum für Leber-, Magen- und Darmerkrankungen
Outcome results
None listed