Children Immune Functions(2)

NCT01731392 | Completed

• 1 other identifier: 10.50.NRC
• Study Type: interventional
• Target: 604
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea; Upper Respiratory Infections

Keywords

Diarrhea; Children; Lactobacilli

Outcome Measures

Primary Outcomes (1)

• Days with diarrhea

  during the 5 months of follow up

Secondary Outcomes (3)

• 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

Study Arms (3)

Milk with Bifidobacteria

EXPERIMENTAL

duration of the treatment is 5 months

Dietary Supplement: Milk with Bifidobacteria

Milk with non replicating lactobacilli

ACTIVE COMPARATOR

duration of the treatment is 5 months

Dietary Supplement: Milk with non replicating lactobacilli

Semi skimmed milk

PLACEBO COMPARATOR

duration of the treatment is 5 months

Dietary Supplement: placebo

Interventions

Milk with Bifidobacteria DIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

Milk with Bifidobacteria

Milk with non replicating lactobacilli DIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

Milk with non replicating lactobacilli

placebo DIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

Semi skimmed milk

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Dept. Nutrition, Faculty of Medicine University of Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Diarrhea; Respiratory Tract Infections

Interventions

Milk

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Saptawati Bardosono, MSc

  Nutrition Department, Faculty of Medicine,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

ID (1)