Children Immune Functions

Not Applicable

Completed

• Conditions: Diarrhea; Upper Respiratory Infections

• Registration Number: NCT01717534
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-24
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days with diarrhea	during 5 months of study period

Secondary Outcome Measures

Name	Time	Method
Severity of upper respiratory infections	during 5 months
Duration of upper respiratory infections	during 5 months
Severity of gastrointestinal infections	during 5 months
Number of episodes of upper respiratory infections	during 5 months

Trial Locations

Locations (2)

Clinical Research Institute; 🇲🇽 Tlalnepantla, Edo. De Méx, Mexico

Centro de Estudios Clinicos de Queretaro S.c.; 🇲🇽 Querétaro, Qro, Mexico