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OpenTrials
Completed

NCT Number: NCT04077034

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

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.

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Key information

Conditions

Immune System Support

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health center Laško, Laško, Slovenia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Formula Bacillus subtilis DE111®

Dietary Supplement

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

Placebo Comparator

Dietary Supplement

Placebo comparator, once a day for 8 weeks

Primary outcomes

  1. The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group

    Time frame: 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.

  2. The incidence of adverse events occuring in the experimental group compared to control group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Deerland Enzymes

Industry

Collaborators

  • University of Ljubljana
  • Vizera d.o.o.

Registry information

Official study title

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

Acronym: IMMUNOFORM

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.