Study on Fermentable Carbohydrates in Healthy Infants (BAMBINOL)

This study has been completed.
Sponsor:
Collaborators:
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan
Institut Investigacio Sanitaria Pere Virgili
Information provided by (Responsible Party):
Ricardo Closa-Monasterolo, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT00808756
First received: December 15, 2008
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Infant
Growth
Nutrition
Healthy
Dietary Supplement: Fermentable carbohydrates.
Other: Standard infant formula.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: Study on Fermentable Carbohydrates in Healthy Infants

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Children well-being and appropriate growth [ Time Frame: up to 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcomes will be metabolic parameters. [ Time Frame: Up to 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 388
Study Start Date: September 2008
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808756

Locations
Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain, 43201
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Spain, 43005
Sponsors and Collaborators
University Rovira i Virgili
Hospital Universitari Joan XXIII de Tarragona.
Hospital Universitari Sant Joan
Institut Investigacio Sanitaria Pere Virgili
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
  More Information

No publications provided by University Rovira i Virgili

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo Closa-Monasterolo, Ricardo Closa Monasterolo, MD, PhD, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT00808756     History of Changes
Other Study ID Numbers: BAMBINOL
Study First Received: December 15, 2008
Last Updated: August 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by University Rovira i Virgili:
Carbohydrates
Infant
Intestine
Faeces
Growth
Diet

ClinicalTrials.gov processed this record on July 24, 2014