Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
374 participants
INTERVENTIONAL
2012-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
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.
heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
Interventions
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heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Months
48 Months
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Angeles Nava Hernández, MD
Role: PRINCIPAL_INVESTIGATOR
Center of Clinical Research of Querétaro
Carlos A. Mena Cedillos, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Institute
Locations
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Clinical Research Institute
Tlalnepantla, Edo. de Méx, Mexico
Centro de Estudios Clinicos de Queretaro S.c.
Querétaro City, Querétaro, Mexico
Countries
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Other Identifiers
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10.42.NRC
Identifier Type: -
Identifier Source: org_study_id