Children Immune Functions

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Diarrhea; Upper Respiratory Infections	Dietary Supplement: heat-treated lactobacilli or placebo	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	374 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Supportive Care
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 Start Date :	October 2012
Actual Primary Completion Date :	July 2013
Actual Study Completion Date :	July 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Heat-treated lactobacilli; One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months.	Dietary Supplement: heat-treated lactobacilli or placebo; Daily supplement of sachet with 1 g of powder over a 5 months period.
Placebo Comparator: Maltodextrin; One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months.	Dietary Supplement: heat-treated lactobacilli or placebo; Daily supplement of sachet with 1 g of powder over a 5 months period.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Days with diarrhea [ Time Frame: during 5 months of study period ]

Secondary Outcome Measures :

1. Number of episodes of upper respiratory infections [ Time Frame: during 5 months ]
2. Duration of upper respiratory infections [ Time Frame: during 5 months ]
3. Severity of upper respiratory infections [ Time Frame: during 5 months ]
4. Severity of gastrointestinal infections [ Time Frame: during 5 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	12 Months to 48 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Mexico
Clinical Research Institute
Tlalnepantla, Edo. De Méx, Mexico, 54055
Centro de Estudios Clinicos de Queretaro S.c.
Querétaro, Qro, Mexico, 76000

Sponsors and Collaborators

Nestlé

Investigators

Principal Investigator:	Angeles Nava Hernández, MD	Center of Clinical Research of Querétaro
Principal Investigator:	Carlos A. Mena Cedillos, MD	Clinical Research Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT01717534 History of Changes
Other Study ID Numbers:	10.42.NRC
First Posted:	October 30, 2012
Last Update Posted:	August 27, 2013
Last Verified:	August 2013

Keywords provided by Nestlé:

Diarrhea; Children; Heat-treated lactobacilli

Additional relevant MeSH terms:

Infection; Diarrhea; Respiratory Tract Infections	Signs and Symptoms, Digestive; Signs and Symptoms; Respiratory Tract Diseases