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Nutritional study on the importance of a probiotic multispecies product for the composition and diversity of the intestinal microbiome with simultaneous administration of antibiotics

Nutritional 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029906
Enrollment
500
Registered
2023-03-20
Start date
2022-07-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotics Associated darrhoea.

Interventions

Group 1: Probiotics: Twice a day for the entire duration of taking the antibiotics and once a day for a period of one week after taking the AB. The dosage is 10 human bacterial strains with at least 5

Sponsors

Institut AllergoSanPharmazeutische Produkte Forschungs- und Vertriebs GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
As secondary goals, the extent to which the probiotic is a side effect will be investigated. influences the following parameters • Influence on the quality of life, as these are typically given during and after antibiotics is reduced. After 12 weeks, the quality of life is queried using the second part of the stool diary.

Countries

Germany

Contacts

Public ContactJoachim Labenz

Fachabteilung Innere Medizin, Diakonie Klinikum Jung-Stilling Siegen, Deutschland

diakonie-klinikum@diakonie-sw.de0049 271 3334569

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026