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Completed

NCT Number: NCT01717534

Children Immune Functions

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.

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Key information

Conditions

Diarrhea Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Upper Respiratory Infections

Age range

12 month–48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Institute, Tlalnepantla, Edo. de Méx, Mexico

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About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

heat-treated lactobacilli or placebo

Dietary Supplement

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

Primary outcomes

  1. Days with diarrhea

    Time frame: during 5 months of study period

Secondary outcomes

  1. Number of episodes of upper respiratory infections

    Time frame: during 5 months

  2. Duration of upper respiratory infections

    Time frame: during 5 months

  3. Severity of upper respiratory infections

    Time frame: during 5 months

  4. Severity of gastrointestinal infections

    Time frame: during 5 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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