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Clinical Trials/DRKS00029906
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

Sponsor
Institut AllergoSanPharmazeutische Produkte Forschungs- und Vertriebs GmbH

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