Status:
COMPLETED
The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Winclove Probiotics B.V.
Conditions:
Antibiotic-associated Diarrhea
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (...
Detailed Description
Certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics remain unclea...
Eligibility Criteria
Inclusion
- children receiving oral or intravenous antibiotics for common infections, willing and able to start the probiotic intervention within 24 hours after the start of antibiotic intake, receiving broad-spectrum antibiotics (broad-spectrum penicillins, cephalosporins, fluoroquinolones, clindamycin).
Exclusion
- prior use of antibiotics within the previous 4 weeks, presence of a severe or generalised infection, history of severe chronic disease (e.g., cancer, inflammatory bowel disease, tuberculosis), critical/life-threatening illness, immunodeficiency, history of pre-existing diarrhoea within the previous 4 weeks, exclusive breastfeeding, allergy or hypersensitivity to any component of the study product, tube-feeding, use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic product containing L rhamnosus GG or S boulardii 14 days before and during the study.
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2021
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT03334604
Start Date
February 16 2018
End Date
May 13 2021
Last Update
October 7 2021
Active Locations (6)
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1
OLVG location West
Amsterdam, Netherlands, 1061
2
Amsterdam UMC, location VUmc
Amsterdam, Netherlands, 1081 HV
3
OLVG location East
Amsterdam, Netherlands, 1092
4
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105