Status:
COMPLETED
Effect of Probiotic Formula DE111® on Immune System in Preschool Children
Lead Sponsor:
Deerland Enzymes
Collaborating Sponsors:
Vizera d.o.o.
University of Ljubljana
Conditions:
Immune System Support
Eligibility:
All Genders
2-6 years
Phase:
NA
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 ef...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04077034
Start Date
April 2 2019
End Date
August 12 2019
Last Update
September 4 2019
Active Locations (5)
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1
Health center Laško
Laško, Slovenia, 3270
2
Pediatrija Krebs
Maribor, Slovenia, 2000
3
Pediatrinja d.o.o.
Maribor, Slovenia, 2000
4
Zasebna otroska in solska ambulanta
Maribor, Slovenia, 2230