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.

Study Overview

• Status: Completed
• Conditions: Diarrhea; Upper Respiratory Infections
• Intervention / Treatment: Dietary supplement: heat-treated lactobacilli or placebo

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 Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Edo. De Méx
    • Tlalnepantla, Edo. De Méx, Mexico, 54055
      • Clinical Research Institute
  • Qro
    • Querétaro, Qro, Mexico, 76000
      • Centro de Estudios Clínicos de Querétaro S.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Days with diarrhea	during 5 months of study period

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of episodes of upper respiratory infections	during 5 months
Duration of upper respiratory infections	during 5 months
Severity of upper respiratory infections	during 5 months
Severity of gastrointestinal infections	during 5 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Angeles Nava Hernández, MD, Center of Clinical Research of Querétaro; Principal Investigator: Carlos A. Mena Cedillos, MD, Clinical Research Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 24, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 27, 2013
• Last Update Submitted That Met QC Criteria: August 26, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Diarrhea; Children; Heat-treated lactobacilli
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Signs and Symptoms, Digestive; Infections; Diarrhea; Respiratory Tract Infections
• Other Study ID Numbers: 10.42.NRC