Antibiotic-associated Diarrhea Clinical Trial
Official title:
A Two-strain Probiotic (L Rhamnosus ATCC 53103 & L Reuteri DSM 29063) Compared With a Single Strain Probiotic (L Rhamnosus ATCC 53103) for Preventing Antibiotic-associated Diarrhea: an Open-label, Randomized, Noninferiority Trial
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 (or as good as) the administration of a recommended probiotic L rhamnosus ATCC 53103 (commercially available as Dicoflor, hereafter a reference product) for the prevention of antibiotic-associated diarrhea in children,
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 collaborating with the St. Hedwig of Silesia Hospital will be recruited.
The involvement of other recruiting wards and/or sites are under consideration provided that
the personnel are adequately trained and competent in conducting clinical trials. The start
of the recruitment is planned in March 2020 and should be completed within the following 2
years.
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.
The control product will be Dicoflor, which is a food supplement containing L rhamnosus ATCC
53103, 5x10^9 CFU, per five drops.
Caregivers will receive oral and written information regarding the study. Written informed
consent will be obtained by the physicians involved in the study. Participants will be
randomized within 24 hours after the initiation of the antibiotic administration.
Throughout the study period, healthcare providers and/or caregivers will record the number
and consistency of stools in a standard stool diary. To record stool consistency, in children
younger than 1 year, the Amsterdam Infant Stool Scale (AISS)9 will be used, and loose or
watery stools will correspond to A-consistency. In children older than 1 year, the Bristol
Stool Form (BSF) scale10 will be used, and loose or watery stools will correspond to scores
of 5- 7. In the case of missing or incomplete data, data from hospital charts will be
obtained. At any time, caregivers will have the right to withdraw the participating child
from the study; they will be not obliged to give reasons for this decision, and there will be
no effect on subsequent physician and/or institutional medical care.
In the event of loose or watery stools, the presence of viral or bacterial pathogens in the
stool samples will be investigated. The presence of viral pathogens will be checked by using
a standard rapid, qualitative, chromatographic immunoassay that simultaneously detects
rotaviruses, adenoviruses, and noroviruses. Standard microbiological techniques will be used
to isolate and identify bacterial pathogens (Salmonella spp, Shigella spp, Campylobacter spp,
and Yersinia spp). C. difficile toxins A and B will be identified by standard enzyme
immunoassay.
All study participants will be followed up for the duration of the intervention (antibiotic
treatment) and then for up to 1 week after the intervention.
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