Study on Fermentable Carbohydrates in Healthy Infants (BAMBINOL)

August 7, 2012 updated by: Ricardo Closa-Monasterolo, University Rovira i Virgili
The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Tarragona, Spain, 43005
        • Hospital Universitari de Tarragona Joan XXIII
    • Tarragona
      • Reus, Tarragona, Spain, 43201
        • Hospital Universitari Sant Joan de Reus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1: Intervention
This group will be fed a diet enriched with fermentable carbohydrates.
Dietary supplement: Fermentable carbohydrates.
Infant formula enriched with fermentable carbohydrates.
Placebo Comparator: 2: Placebo.
The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins & minerals).
Other: Standard infant formula.
Standard infant formula.
No Intervention: BF
The 2 intervention groups will be compared with a breast-fed infants control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Children well-being and appropriate growth
Time Frame: up to 4 months
up to 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcomes will be metabolic parameters.
Time Frame: Up to 4 months
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rovira i Virgili

Collaborators

Hospital Universitari Joan XXIII de Tarragona.
Institut Investigacio Sanitaria Pere Virgili
Hospital Universitari Sant Joan

Investigators

  • Principal Investigator: Ricardo Closa, PhD, Prof, University Rovira i Virgili & Hospital Universitari Joan XXIII
  • Principal Investigator: Joaquin Escribano, PhD, Prof, Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.
  • Study Director: Veronica Luque, PhD, University Rovira i Virgili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BAMBINOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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