ProbioKid as Prevention Among Kids With Frequent URTI
Experience of Using ProbioKid for Children That Often Get Sick as a Prevention for Acute Respiratory Diseases
1 other identifier
interventional
56
0 countries
N/A
Brief Summary
This study was designed to evaluate the preventive efficacy of a 6-week prophylactic administration of Probiokid® on the incidence of respiratory infections and related complications in frequently sick children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
September 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2017
CompletedFirst Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedAugust 25, 2020
July 1, 2020
9 months
August 20, 2020
August 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and duration of URTI and related complications
Difference between group in the change \[ follow-up - baseline\]
6 months prior to enrollment, and 6 months follow-up
Secondary Outcomes (5)
Monthly incidence of URTI
6 months after the intervention
Monthly number of visits to a specialized physician
6 months after the intervention
Resistance index
6 months prior to enrollment and 6 months after intervention
Individual complication diagnosed (number of cases)
6 months prior to enrollment and 6 months after intervention
Number of antibiotics prescriptions
6 months prior to enrollment and 6 months after intervention
Study Arms (2)
Intervention arm
EXPERIMENTALChildren in this arm were given ProbioKid®; one capsule daily, for 6 weeks.
Pragmatic arm
OTHERChildren in this arm received standard of care as usual without a preventive intervention
Interventions
Probiokid formulation includes three probiotic strains and fructooligosaccharides.
Eligibility Criteria
You may qualify if:
- Age of children from 3 to 10 years,
- High frequency of acute respiratory tract infections, characterized by a resistance index more than 0.33 (i.e. ARIs more often than once every 3 months).
- Absence of other medications that affect the immune system in the treatment regimen (except for antibiotics, as per the care provider's judgment).
You may not qualify if:
- Chronic pathological conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu V. Marushko, MD
Bogomolets National Medical University (Kiev, Ukraine)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 25, 2020
Study Start
September 14, 2016
Primary Completion
June 25, 2017
Study Completion
June 25, 2017
Last Updated
August 25, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share