Children Immune Functions

Nestlé

Status: Completed

Conditions: Upper Respiratory Infections; Diarrhea

Treatments: Dietary Supplement: heat-treated lactobacilli or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01717534

10.42.NRC

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 374 patients

Sex: All

Ages: 12 to 48 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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374 participants in 2 patient groups, including a placebo group

Heat-treated lactobacilli

Experimental group

Description:

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.

Treatment:

Dietary Supplement: heat-treated lactobacilli or placebo

Maltodextrin

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: heat-treated lactobacilli or placebo