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

Deerland Probiotics & Enzymes

Status: Completed

Conditions: Immune System Support

Treatments: Dietary Supplement: Placebo comparator; Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04077034

IMMUNO-01

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Probiotic DE111®

Treatment:

Dietary Supplement: Probiotic Formula Bacillus subtilis DE111®

Control group

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo comparator