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

Not Applicable

Completed

• Conditions: Immune System Support
• Interventions: Dietary Supplement: Placebo comparator; Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®

• Registration Number: NCT04077034
• Lead Sponsor: Deerland Enzymes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Status Verified: 2019-08
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-30
• Last Update Submitted: 2019-08-30
• Study First Posted: 2019-09-04
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo comparator	Placebo
Experimental group	Probiotic Formula Bacillus subtilis DE111®	Probiotic DE111®

Primary Outcome Measures

Name	Time	Method
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group	12-week study period (consisting of 8-week treatment plus 4-week follow-up)	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.
The incidence of adverse events occuring in the experimental group compared to control group	12-week study period (consisting of 8-week treatment plus 4-week follow-up)	Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.

Trial Locations

Locations (5)

Health center Laško; 🇸🇮 Laško, Slovenia

Pediatrija Krebs; 🇸🇮 Maribor, Slovenia

Pediatrinja d.o.o.; 🇸🇮 Maribor, Slovenia

Zasebna otroska in solska ambulanta; 🇸🇮 Maribor, Slovenia

Health Center Nova Gorica; 🇸🇮 Šempeter Pri Gorici, Slovenia