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NCT00808756 Clinical Trial

Study on Fermentable Carbohydrates in Healthy Infants

Healthy Clinical Trial

— BAMBINOL  

Official title:
Study on Fermentable Carbohydrates in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00808756
Other study ID # BAMBINOL
Secondary ID
Status Completed
Phase N/A
First received December 15, 2008
Last updated August 7, 2012
Start date September 2008
Est. completion date March 2012

Study information
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

Clinical Trial Summary

The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Description:

Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fermentable carbohydrates.
Infant formula enriched with fermentable carbohydrates.
Other:
• Standard infant formula.
Standard infant formula.

Locations
Country Name City State
Spain Hospital Universitari Sant Joan de Reus Reus Tarragona
Spain Hospital Universitari de Tarragona Joan XXIII Tarragona

Sponsors (4)
Lead Sponsor Collaborator
University Rovira i Virgili Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan, Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome
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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