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Children Immune Functions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01717534
First received: October 24, 2012
Last updated: August 26, 2013
Last verified: August 2013

October 24, 2012
August 26, 2013
October 2012
July 2013   (final data collection date for primary outcome measure)
Days with diarrhea [ Time Frame: during 5 months of study period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01717534 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Children Immune Functions
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Diarrhea
  • Upper Respiratory Infections
Dietary Supplement: heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
  • 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.

    Intervention: Dietary Supplement: heat-treated lactobacilli or placebo
  • 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.

    Intervention: Dietary Supplement: heat-treated lactobacilli or placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
374
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
12 Months to 48 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01717534
10.42.NRC
No
Nestlé
Nestlé
Not Provided
Principal Investigator: Angeles Nava Hernández, MD Center of Clinical Research of Querétaro
Principal Investigator: Carlos A. Mena Cedillos, MD Clinical Research Institute
Nestlé
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP