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
721 participants
INTERVENTIONAL
2013-12-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Formula + placebo
Probiotic
Formula + probiotic
Formula + probiotic
Probiotic
Breastfed + probiotic
Breastfed + probiotic
Probiotic
Breastfed + placebo
Probiotic
Interventions
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Probiotic
Eligibility Criteria
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Inclusion Criteria
* healthy newborns
* born by Cesarean section
* singleton birth
* Age at enrollment in the study \< 24h
* birth weight ≥ 2500g and ≤ 4300g
* gestational age ≥ 37 weeks and ≤ 42 weeks
Exclusion Criteria
* prenatal and/or postnatal diseases
* parents are expected to have difficulty complying with the feeding regime
* planned re-admittance to the hospital in the first 14 days of life
* antibiotic treatment at the time of enrollment in the study
1 Minute
24 Hours
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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Klinikum Ernst v. Bergmann GmbH
Potsdam, , Germany
Countries
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Other Identifiers
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12.14.INF
Identifier Type: -
Identifier Source: org_study_id
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