Helicobacter pylori infection/ condition after eradication
Conditions
Interventions
Group 1: Probiotics: Twice daily during intake of Pylera (10 days). The probiotics contains 10 human derived bacterial strains with at least 5 billion organisms per single dose.
Group 2: Probiotics: T
Sponsors
Institut AllergoSan Pharmazeutische Produkte Forschungs- und Vertriebs GmbH
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: • H. pylori induced gastritis with dyspeptic symptoms or uncomplicated duodenal ulcers • No prior treatment with Pylera • Routinely scheduled gastroscopy • Recommended BQT • Written patient consent after comprehensive information
Exclusion criteria
Exclusion criteria: • Active gastrointestinal disease like IBS, celiac disease, recent active gastrointestinal disease like IBS, celiac disease, recent gastroenteritis • Gi-tract surgery (except appendicitis) • Antibiotics, PPI, H2-antagonist-, P-CAB- or probiotic intake within the last 3 months, NSAID-intake within the last 3 weeks • Diarrhea within the last 4 weeks • Severe disease or conditions (heart- or kidney insufficiency, immune deficiency) • Mental disorders which may hinder compliance with the study protocol • Advanced malignant tumors • Pregnancy or breast feeding • Allergy to probiotics or components of the BQT • Patients with sepsis, acute cancer or dialysis requirement • Accompanying circumstances that make it difficult to take probiotics consistently (e.g. dementia, ventilation, planned surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to test whether and to what extent oral consumption of the multispecies probiotic OMNi-BiOTiC® 10 changes diversity and composition of the intestinal microbiome in patients with standard HP therapy with PPI plus Pylera at time points T10 (10th day of Pylera therapy) and TER (time point of eradication test) (compared to T0 (time point of start of Pylera intake, baseline) between probiotics and placebo groups). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of this study are to investigate in persons with HP eradication therapy with Pylera the influence of the multispecies probiotic OMNi-BiOTiC® 10 compared to placebo on • The composition of the stomach microbiota at time point T10 (compared to T0) and TER (compared to T0 and T10) • The composition of the oral microbiota at time point T10 (compared to T0) and TER (compared to T0 and T10) • The composition of the resistome at time point T10 (compared to T0) and TER (compared to T0 and T10) • Therapy compliance of patients | — |
Countries
Germany, Italy
Contacts
Public ContactVerena Stiegelbauer
Institut AllergoSan Pharmazeutische Produkte Forschungs- und Vertriebs GmbH
Outcome results
None listed