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

NCT04077034 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-09-04

No results posted yet for this study

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

  • Immune System Support

Interventions

DIETARY_SUPPLEMENT

Probiotic Formula Bacillus subtilis DE111®

Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks

DIETARY_SUPPLEMENT

Placebo comparator

Placebo comparator, once a day for 8 weeks

Sponsors & Collaborators

  • Vizera d.o.o.

    collaborator INDUSTRY

  • University of Ljubljana

    collaborator OTHER

  • Deerland Enzymes

    lead INDUSTRY

Principal Investigators

  • Lilijana Kocijancic Besednjak, MD, PhD · Health Center Nova Gorica

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2019-08-12
Completion
2019-08-12

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04077034 on ClinicalTrials.gov