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
604 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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Detailed Description
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The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.
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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Milk with Bifidobacteria
duration of the treatment is 5 months
Milk with Bifidobacteria
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Milk with non replicating lactobacilli
duration of the treatment is 5 months
Milk with non replicating lactobacilli
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Semi skimmed milk
duration of the treatment is 5 months
placebo
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Interventions
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Milk with Bifidobacteria
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Milk with non replicating lactobacilli
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
placebo
A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
Eligibility Criteria
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Inclusion Criteria
* Healthy children aged 1 to 3 years that are no more breastfed.
* Go to a selected nursery and / or pediatrician.
* Parents must have a phone at home or a cellular phone to call the paediatrician.
* No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
* Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
* Children not being intensive consumers of regular yoghurts
Exclusion Criteria
* Used antibiotics within the last 30 days prior to V1 (baseline visit).
* Congenital or chronic disease.
* Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
* Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
1 Year
3 Years
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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Saptawati Bardosono, MSc
Role: PRINCIPAL_INVESTIGATOR
Nutrition Department, Faculty of Medicine,
Locations
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Dept. Nutrition, Faculty of Medicine University of Indonesia
Jakarta, , Indonesia
Countries
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Other Identifiers
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10.50.NRC
Identifier Type: -
Identifier Source: org_study_id