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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2019-08-12

Brief Summary

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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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Detailed Description

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Conditions

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Immune System Support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental group

Probiotic DE111®

Group Type EXPERIMENTAL

Probiotic Formula Bacillus subtilis DE111®

Intervention Type DIETARY_SUPPLEMENT

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

Control group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator, once a day for 8 weeks

Interventions

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Probiotic Formula Bacillus subtilis DE111®

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

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator

Placebo comparator, once a day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes