DRKS00029906RecruitingUnknown
utritional study on the importance of a probiotic multispecies product for the composition and diversity of the intestinal microbiome with simultaneous administration of antibiotics - OMNi-BiOTiC® 10
Institut AllergoSanPharmazeutische Produkte Forschungs- und Vertriebs GmbH0 sites500 target enrollmentStarted: March 20, 2023Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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