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

August 30, 2019 updated by: Deerland Enzymes

A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula 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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Laško, Slovenia, 3270
        • Health center Laško
      • Maribor, Slovenia, 2000
        • Pediatrija Krebs
      • Maribor, Slovenia, 2000
        • Pediatrinja d.o.o.
      • Maribor, Slovenia, 2230
        • Zasebna otroska in solska ambulanta
      • Šempeter Pri Gorici, Slovenia, 5290
        • Health Center Nova Gorica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Placebo
Placebo comparator, once a day for 8 weeks
Experimental: Experimental group
Probiotic DE111®
Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-week study period (consisting of 8-week treatment plus 4-week follow-up)
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.
12-week study period (consisting of 8-week treatment plus 4-week follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lilijana Kocijancic Besednjak, MD, PhD, Health Center Nova Gorica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

August 12, 2019

Study Completion (Actual)

August 12, 2019

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

September 4, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IMMUNO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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