Children Immune Functions(2)

Nestlé

Status: Completed

Conditions: Upper Respiratory Infections; Diarrhea

Treatments: Dietary Supplement: placebo; Dietary Supplement: Milk with Bifidobacteria; Dietary Supplement: Milk with non replicating lactobacilli

Study type: Interventional

Funder types: Industry

Identifiers

NCT01731392

10.50.NRC

Details and patient eligibility

About

To investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Full description

Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.

The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Enrollment: 604 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parents written and signed informed consent for participation in the study.
• Healthy children aged 1 to 3 years that are no more breastfed.
• Go to a selected nursery and / or pediatrician.
• Parents must have a phone at home or a cellular phone to call the paediatrician.
• No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
• Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
• Children not being intensive consumers of regular yoghurts

Exclusion criteria

• Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
• Used antibiotics within the last 30 days prior to V1 (baseline visit).
• Congenital or chronic disease.
• Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
• Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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604 participants in 3 patient groups, including a placebo group

Milk with Bifidobacteria

Experimental group

Description:

duration of the treatment is 5 months

Treatment:

Dietary Supplement: Milk with Bifidobacteria

Milk with non replicating lactobacilli

Active Comparator group

Description:

duration of the treatment is 5 months

Treatment:

Dietary Supplement: Milk with non replicating lactobacilli

Semi skimmed milk

Placebo Comparator group

Description:

duration of the treatment is 5 months

Treatment:

Dietary Supplement: placebo