Clinical trial NCT01717534: Children Immune Functions
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Upper Respiratory Infections
Keywords: Diarrhea
Children
Heat-treated lactobacilli
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 374
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Days with diarrhea
timeFrame: during 5 months of study period
Secondary outcomes:
measure: Number of episodes of upper respiratory infections
timeFrame: during 5 months
measure: Duration of upper respiratory infections
timeFrame: during 5 months
measure: Severity of upper respiratory infections
timeFrame: during 5 months
measure: Severity of gastrointestinal infections
timeFrame: during 5 months
Other outcomes:
Locations:
city: Tlalnepantla
country: Mexico
facility: Clinical Research Institute
state: Edo. De Méx
city: Querétaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro S.c.
state: Qro
Study officials:
affiliation: Center of Clinical Research of Querétaro
name: Angeles Nava Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Institute
name: Carlos A. Mena Cedillos, MD
role: PRINCIPAL_INVESTIGATOR
References: