Children Immune Functions

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

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

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.

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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.

Conditions

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Diarrhea Upper Respiratory Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Heat-treated lactobacilli

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.

Group Type EXPERIMENTAL

heat-treated lactobacilli or placebo

Intervention Type DIETARY_SUPPLEMENT

Daily supplement of sachet with 1 g of powder over a 5 months period.

Maltodextrin

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.

Group Type PLACEBO_COMPARATOR

heat-treated lactobacilli or placebo

Intervention Type DIETARY_SUPPLEMENT

Daily supplement of sachet with 1 g of powder over a 5 months period.

Interventions

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heat-treated lactobacilli or placebo

Daily supplement of sachet with 1 g of powder over a 5 months period.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Healthy children aged 1 to 4 years
3. No more breastfed.
4. Daily home cared and going to a selected pediatrician.
5. Parents must have a phone at home or a cellular phone to call the paediatrician.
6. No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.
7. Children not being intensive consumers of regular yoghurts
8. Parents are able to keep a daily record of symptoms and to administrate the study products.

Exclusion Criteria

1. Vaccine administration within the last 3 months prior study start.
2. Used antibiotics within the last month
3. Congenital or chronic disease.
4. Any kind of immunodeficiency or allergy.
5. Acute infection or fever.
6. Significant illness within the two weeks prior to the start of the study.

Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes