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Children Immune Functions

Primary Purpose

Diarrhea, Upper Respiratory Infections

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
heat-treated lactobacilli or placebo
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diarrhea focused on measuring Diarrhea, Children, Heat-treated lactobacilli

Eligibility Criteria

12 Months - 48 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinical Research Institute
  • Centro de Estudios Clinicos de Queretaro S.c.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Heat-treated lactobacilli

Maltodextrin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Days with diarrhea

Secondary Outcome Measures

Number of episodes of upper respiratory infections
Duration of upper respiratory infections
Severity of upper respiratory infections
Severity of gastrointestinal infections

Full Information

First Posted
October 24, 2012
Last Updated
August 26, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT01717534
Brief Title
Children Immune Functions
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Upper Respiratory Infections
Keywords
Diarrhea, Children, Heat-treated lactobacilli

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heat-treated lactobacilli
Arm Type
Experimental
Arm Description
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.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
heat-treated lactobacilli or placebo
Intervention Description
Daily supplement of sachet with 1 g of powder over a 5 months period.
Primary Outcome Measure Information:
Title
Days with diarrhea
Time Frame
during 5 months of study period
Secondary Outcome Measure Information:
Title
Number of episodes of upper respiratory infections
Time Frame
during 5 months
Title
Duration of upper respiratory infections
Time Frame
during 5 months
Title
Severity of upper respiratory infections
Time Frame
during 5 months
Title
Severity of gastrointestinal infections
Time Frame
during 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeles Nava Hernández, MD
Organizational Affiliation
Center of Clinical Research of Querétaro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos A. Mena Cedillos, MD
Organizational Affiliation
Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Institute
City
Tlalnepantla
State/Province
Edo. De Méx
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Centro de Estudios Clinicos de Queretaro S.c.
City
Querétaro
State/Province
Qro
ZIP/Postal Code
76000
Country
Mexico

12. IPD Sharing Statement

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Children Immune Functions

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