Status:
UNKNOWN
L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Adamed Pharma S.A.
Conditions:
Antibiotic-associated Diarrhea
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study will use a noninferiority design to examine whether the administration of L rhamnosus ATCC 53103 \& L reuteri DSM 29063 (Flostrum Baby) is no worse than ...
Detailed Description
The recruitment will take place in hospitalized patients at the Pediatric Department of St. Hedwig of Silesia Hospital, Trzebnica, Poland. Additionally, patients treated at the out-patient clinics col...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- age younger than 18 years;
- oral or intravenous antibiotic therapy which started within 24 hours of enrolment;
- signed informed consent.
- Exclusion criteria:
- pre-existing acute or chronic diarrhea, history of chronic gastrointestinal disease (e.g. inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) or other severe chronic diseases (eg, neoplastic diseases),
- major medical problems (eg. immunocompromised, major developmental or genetic abnormality);
- taking any of the study products (or probiotic strains included in the study products) at the time of study commencement;
- use of antibiotics within 4 weeks prior to enrolment,
- prematurity;
- exclusive breastfeeding.
Exclusion
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
892 Patients enrolled
Trial Details
Trial ID
NCT04277156
Start Date
February 1 2020
End Date
December 1 2023
Last Update
February 20 2020
Active Locations (1)
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1
Department of Paediatrics, St. Hedwig of Silesia Hospital
Trzebnica, Poland, 55-100