Children Immune Functions

Study Overview
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Brief Summary
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The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.

Detailed Description
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The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children

Conditions
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Diarrhea, Upper Respiratory Infections

Intervention / Treatment
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* Dietary Supplement: heat-treated lactobacilli or placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure. Healthy children aged 1 to 4 years No more breastfed. Daily home cared and going to a selected pediatrician. Parents must have a phone at home or a cellular phone to call the paediatrician. No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period. Children not being intensive consumers of regular yoghurts Parents are able to keep a daily record of symptoms and to administrate the study products. Exclusion Criteria: Vaccine administration within the last 3 months prior study start. Used antibiotics within the last month Congenital or chronic disease. Any kind of immunodeficiency or allergy. Acute infection or fever. Significant illness within the two weeks prior to the start of the study.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat-treated lactobacilli<br>One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months. | Dietary Supplement: heat-treated lactobacilli or placebo<br>* Daily supplement of sachet with 1 g of powder over a 5 months period.<br>|
| Placebo Comparator: Maltodextrin<br>One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months. | Dietary Supplement: heat-treated lactobacilli or placebo<br>* Daily supplement of sachet with 1 g of powder over a 5 months period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days with diarrhea |  | during 5 months of study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of upper respiratory infections |  | during 5 months | 
| Duration of upper respiratory infections |  | during 5 months | 
| Severity of upper respiratory infections |  | during 5 months | 
| Severity of gastrointestinal infections |  | during 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diarrhea, Children, Heat-treated lactobacilli