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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077034
Acronym
IMMUNOFORM
Enrollment
102
Registered
2019-09-04
Start date
2019-04-02
Completion date
2019-08-12
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System Support

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.

Interventions

DIETARY_SUPPLEMENTProbiotic Formula Bacillus subtilis DE111®

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

DIETARY_SUPPLEMENTPlacebo comparator

Placebo comparator, once a day for 8 weeks

Sponsors

Vizera d.o.o.
CollaboratorINDUSTRY
University of Ljubljana
CollaboratorOTHER
Deerland Enzymes
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group12-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 group12-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.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026