Effect of Probiotic Formula DE111® on Immune System in Preschool Children
IMMUNOFORM
A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
1 other identifier
interventional
102
1 country
5
Brief Summary
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
5 active sites
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
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 4, 2019
CompletedSeptember 4, 2019
August 1, 2019
4 months
August 26, 2019
August 30, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
12-week study period (consisting of 8-week treatment plus 4-week follow-up)
The incidence of adverse events occuring in the experimental group compared to control group
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.
12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Study Arms (2)
Experimental group
EXPERIMENTALProbiotic DE111®
Control group
PLACEBO COMPARATORPlacebo
Interventions
Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
Eligibility Criteria
You may qualify if:
- signed informed consent by at least one parent or legal guardian
- children aged 2 to 6 years
- attending or about to start attending day-care
You may not qualify if:
- body weight at birth \<2500g
- gestational age \<37 weeks
- severe chronic illness
- regular use of medication
- immunodeficiency
- parent or legal guardian not able to understand and comply with requirements of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deerland Enzymeslead
- Vizera d.o.o.collaborator
- University of Ljubljanacollaborator
Study Sites (5)
Health center Laško
Laško, 3270, Slovenia
Pediatrija Krebs
Maribor, 2000, Slovenia
Pediatrinja d.o.o.
Maribor, 2000, Slovenia
Zasebna otroska in solska ambulanta
Maribor, 2230, Slovenia
Health Center Nova Gorica
Šempeter pri Gorici, 5290, Slovenia
Study Officials
- PRINCIPAL INVESTIGATOR
Lilijana Kocijancic Besednjak, MD, PhD
Health Center Nova Gorica
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 4, 2019
Study Start
April 2, 2019
Primary Completion
August 12, 2019
Study Completion
August 12, 2019
Last Updated
September 4, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share