Children Immune Functions - Full Text View

Purpose

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	Intervention
Diarrhea Upper Respiratory Infections	Dietary Supplement: heat-treated lactobacilli or placebo


Study Type:	Interventional
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
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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Lactobacillus

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:

Days with diarrhea [ Time Frame: during 5 months of study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of episodes of upper respiratory infections [ Time Frame: during 5 months ] [ Designated as safety issue: No ]
Duration of upper respiratory infections [ Time Frame: during 5 months ] [ Designated as safety issue: No ]
Severity of upper respiratory infections [ Time Frame: during 5 months ] [ Designated as safety issue: No ]
Severity of gastrointestinal infections [ Time Frame: during 5 months ] [ Designated as safety issue: No ]


Enrollment:	374
Study Start Date:	October 2012
Study Completion Date:	July 2013
Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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


Ages Eligible for Study:	12 Months to 48 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.
Healthy children aged 1 to 4 years
No more breastfed.
Daily home cared and going to a selected pediatrician.
Parents must have a phone at home or a cellular phone to call the paediatrician.
No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.
Children not being intensive consumers of regular yoghurts
Parents are able to keep a daily record of symptoms and to administrate the study products.

Exclusion Criteria:

Vaccine administration within the last 3 months prior study start.
Used antibiotics within the last month
Congenital or chronic disease.
Any kind of immunodeficiency or allergy.
Acute infection or fever.
Significant illness within the two weeks prior to the start of the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717534

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

No publications provided


Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT01717534 History of Changes
Other Study ID Numbers:	10.42.NRC
Study First Received:	October 24, 2012
Last Updated:	August 26, 2013
Health Authority:	Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Nestlé:


Diarrhea Children Heat-treated lactobacilli

Additional relevant MeSH terms:


Respiratory Tract Infections Infection Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2015