utritional study on the importance of a probiotic multispecies product for the composition and diversity of the intestinal microbiome with simultaneous administration of antibiotics
- Conditions
- Antibiotics Associated darrhoea.
- Registration Number
- DRKS00029906
- Lead Sponsor
- Institut AllergoSanPharmazeutische Produkte Forschungs- und Vertriebs GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
According to medical assessment, necessary antibiotic therapy of a bacterial infectious disease (e.g. bronchopulmonary infections, urinary tract infections) by broad-spectrum antibiotics administered orally or intravenously (e.g. clindamycin, Cephalosporins, fluoroquinolones, macrolides, penicillins)
• The possibility of using antibiotics within 24 hours with the consumption of Study medication to begin
• Written consent after comprehensive information
• No fundamental changes in dietary patterns during the Participation in studies
Antibiotic use within the last 4 weeks before the start of the study
• Planned intestinal lavage (e.g. before colonoscopy)
• Diarrhoeal disease within the last 4 weeks before the start of studies
• Consumption of other probiotics within the last 4 weeks
• Regular use of laxatives
• Consumption of peristaltic inhibitors
• Chronic diarrhoeal disease (e.g. chronic inflammatory bowel disease or Malassimilation)
• Immunosuppression due to illness and/or medication
• Patients with sepsis, current cancer or dialysis
• Accompanying circumstances that lead to a consistent implementation of probiotics intake and the
Do not allow keeping a diary (e.g. dementia, ventilation, planned surgery)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary aim of the study is to clarify whether and to what extent the consumption of the Multispecies probiotic OMNi-BiOTiC® 10 during and shortly after an antibiotic Treatment affects the diversity and composition of the intestinal microbiome. This is analyzed by 16S rRNA gene sequencing
- Secondary Outcome Measures
Name Time Method As secondary goals, the extent to which the probiotic is a side effect will be investigated.<br>influences the following parameters<br>• Influence on the quality of life, as these are typically given during and after antibiotics is reduced.<br>After 12 weeks, the quality of life is queried using the second part of the stool diary.