Children Immune Functions

Société des Produits Nestlé (SPN)374 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

374

Conditions

Diarrhea Upper Respiratory Infections

Interventions

heat-treated lactobacilli or placeboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 48 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Clinical Research Institute

Tlalnepantla, Edo. de Méx, Mexico

Centro de Estudios Clinicos de Queretaro S.c.

Querétaro City, Querétaro, Mexico

Outcomes

Primary Outcomes

Days with diarrhea

Time frame: during 5 months of study period

Secondary Outcomes

Number of episodes of upper respiratory infections

Time frame: during 5 months

Duration of upper respiratory infections

Time frame: during 5 months

Severity of upper respiratory infections

Time frame: during 5 months

Severity of gastrointestinal infections

Time frame: during 5 months

Data from ClinicalTrials.gov

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