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

Immune System Support Clinical Trial

— IMMUNOFORM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077034
• Other study ID #: IMMUNO-01
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: August 12, 2019

Study information

• Verified date: August 2019
• Source: Deerland Enzymes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 12, 2019
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune System Support

Intervention

Dietary Supplement:
• Probiotic Formula Bacillus subtilis DE111®
Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
• Placebo comparator
Placebo comparator, once a day for 8 weeks

Locations

Country	Name	City	State
Slovenia	Health Center Nova Gorica	Šempeter Pri Gorici
Slovenia	Health center Laško	Laško
Slovenia	Pediatrija Krebs	Maribor
Slovenia	Pediatrinja d.o.o.	Maribor
Slovenia	Zasebna otroska in solska ambulanta	Maribor

Sponsors (3)

Lead Sponsor	Collaborator
Deerland Enzymes	University of Ljubljana, Vizera d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group	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)
Primary	The incidence of adverse events occuring in the experimental group compared to control group	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)