Children Immune Functions

NCT01717534 | Completed

• 1 other identifier: 10.42.NRC
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 2

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.

Conditions

Diarrhea; Upper Respiratory Infections

Keywords

Diarrhea; Children; Heat-treated lactobacilli

Outcome Measures

Primary Outcomes (1)

• Days with diarrhea

  during 5 months of study period

Secondary Outcomes (4)

• 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

Study Arms (2)

Heat-treated lactobacilli

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Interventions

heat-treated lactobacilli or placebo DIETARY_SUPPLEMENT

Daily supplement of sachet with 1 g of powder over a 5 months period.

Heat-treated lactobacilli; Maltodextrin

Eligibility Criteria

• Age: 12 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (2)

Clinical Research Institute

Tlalnepantla, Edo. de Méx, 54055, Mexico

Location

Centro de Estudios Clinicos de Queretaro S.c.

Querétaro City, Querétaro, 76000, Mexico

Location

MeSH Terms

Conditions

Diarrhea; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Respiratory Tract Diseases

Study Officials

• Angeles Nava Hernández, MD

  Center of Clinical Research of Querétaro

  PRINCIPAL INVESTIGATOR

• Carlos A. Mena Cedillos, MD

  Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

ME (2)