NCT01731392CompletedNot Applicable
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children
Société des Produits Nestlé (SPN)1 site in 1 country604 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 604
- Locations
- 1
- Primary Endpoint
- Days with diarrhea
Study Overview
Brief Summary
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Days with diarrhea
Time Frame: during the 5 months of follow up
Secondary Outcomes
- Number of episodes of Upper Respiratory Infections(5 months)
- Duration of episodes of Upper Respiratory Infections(5 months)
- Severity of episodes of Upper Respiratory Infections(5 months)
Investigators
Study Sites (1)
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