- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04077034
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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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