L Rhamnosus ATCC 53103 & L Reuteri DSM 29063 Compared With L Rhamnosus ATCC 53103 for Preventing AAD in Children (FLOSTRUM)
Antibiotic-associated Diarrhea
About this trial
This is an interventional prevention trial for Antibiotic-associated Diarrhea
Eligibility Criteria
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.
Sites / Locations
- Department of Paediatrics, St. Hedwig of Silesia Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Flostrum Baby
Dicoflor
The test product will be Flostrum Baby, which is a food supplement consisting of two bacterial strains: Lactobacillus rhamnosus ATCC 53103 and Lactobacillus reuteri DSM 29063, 5x10^9 CFU and 1x10^8 CFU, respectively, per seven drops. Flostrum Baby - in children below 12 years of age, 7 drops, twice daily; in children older than 12 years, 14 drops, twice daily.
The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC 53103, 5x10^9 CFU, per five drops. Dicoflor - the manufacturer recommends 5-10 drops daily, with no age specification. For the purposes of this study, 5 drops, twice daily, in children below 12 years of age; 10 drops, twice daily, in children older than 12 years.