Clinical Trials Directory

Trials / Completed

CompletedNCT04077034

Effect of Probiotic Formula DE111® on Immune System in Preschool Children

A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Deerland Enzymes · Industry
Sex
All
Age
2 Years – 6 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbiotic Formula Bacillus subtilis DE111®Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
DIETARY_SUPPLEMENTPlacebo comparatorPlacebo comparator, once a day for 8 weeks

Timeline

Start date
2019-04-02
Primary completion
2019-08-12
Completion
2019-08-12
First posted
2019-09-04
Last updated
2019-09-04

Locations

5 sites across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT04077034. Inclusion in this directory is not an endorsement.