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Children Immune Functions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01717534
First received: October 24, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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:

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
Estimated Study Completion Date: July 2013
Estimated 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:

  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
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: March 19, 2013
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Nestlé:
Diarrhea
Children
Heat-treated lactobacilli

Additional relevant MeSH terms:
Diarrhea
Respiratory Tract Infections
Common Cold
Signs and Symptoms, Digestive
Signs and Symptoms
 Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 22, 2013