Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.
1 other identifier
interventional
400
1 country
1
Brief Summary
To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 9, 2014
May 1, 2014
6 months
September 9, 2013
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of the incidence of loose/watery stools following antibiotic treatment in children.
19-24 days
Study Arms (2)
Probiotics
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
- Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
- Children whose parents or legal caregivers have signed the informed consent to participate in the study.
You may not qualify if:
- Chronic intestinal disease.
- Current immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrhoeal disease.
- Known hypersensitivity to any of the ingredients in the probiotic product or the placebo \[potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture\].
- Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Probi ABlead
Study Sites (1)
Multicenter study at 13 health care centers in Warsaw
Warsaw, Poland
Related Publications (1)
Olek A, Woynarowski M, Ahren IL, Kierkus J, Socha P, Larsson N, Onning G. Efficacy and Safety of Lactobacillus plantarum DSM 9843 (LP299V) in the Prevention of Antibiotic-Associated Gastrointestinal Symptoms in Children-Randomized, Double-Blind, Placebo-Controlled Study. J Pediatr. 2017 Jul;186:82-86. doi: 10.1016/j.jpeds.2017.03.047. Epub 2017 Apr 21.
PMID: 28438377DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2013
First Posted
September 12, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2014
Study Completion
May 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-05