Children Immune Functions

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717534
• Other study ID #: 10.42.NRC
• Status: Completed
• Phase: N/A
• First received: October 24, 2012
• Last updated: August 26, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 48 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diarrhea
• Respiratory Tract Infections
• Upper Respiratory Infections

Intervention

Dietary Supplement:
• heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.

Locations

Country	Name	City	State
Mexico	Centro de Estudios Clinicos de Queretaro S.c.	Querétaro	Qro
Mexico	Clinical Research Institute	Tlalnepantla	Edo. De Méx

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days with diarrhea		during 5 months of study period	No
Secondary	Number of episodes of upper respiratory infections		during 5 months	No
Secondary	Duration of upper respiratory infections		during 5 months	No
Secondary	Severity of upper respiratory infections		during 5 months	No
Secondary	Severity of gastrointestinal infections		during 5 months	No