Healthy Clinical Trial
— BAMBINOLOfficial title:
Study on Fermentable Carbohydrates in Healthy Infants
Verified date | August 2012 |
Source | University Rovira i Virgili |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.
Status | Completed |
Enrollment | 388 |
Est. completion date | March 2012 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 1 Month |
Eligibility |
Inclusion Criteria: - Infants born in Reus and Tarragona area - Healthy - Normal feeding behaviour Exclusion Criteria: - Serious respiratory, neurological, gastrointestinal or metabolic disorders - Infections or other serious diseases that could interfere in normal feeding or growth - Parents or guardians cannot be expected to comply with protocol - Parents or guardians have not command on Catalan or Spanish language |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Sant Joan de Reus | Reus | Tarragona |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona |
Lead Sponsor | Collaborator |
---|---|
University Rovira i Virgili | Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan, Institut Investigacio Sanitaria Pere Virgili |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children well-being and appropriate growth | up to 4 months | Yes | |
Secondary | Secondary outcomes will be metabolic parameters. | Up to 4 months | Yes |
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