Study on Fermentable Carbohydrates in Healthy Infants. - Full Text View

Sponsors and Collaborators:	University Rovira i Virgili Hospital Universitari Joan XXIII de Tarragona. Hospital Universitari Sant Joan Institut Investigacio Sanitaria Pere Virgili
Information provided by:	University Rovira i Virgili
ClinicalTrials.gov Identifier:	NCT00808756

Purpose

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

Condition	Intervention
Carbohydrates Infant Intestine Faeces Growth Nutition	Dietary Supplement: Fermentable carbohydrates. Other: Standard infant formula.

MedlinePlus related topics: Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	Study on Fermentable Carbohydrates in Healthy Infants.

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Intervention: Experimental This group will be fed a diet enriched with fermentable carbohydrates.	Dietary Supplement: Fermentable carbohydrates. Infant formula enriched with fermentable carbohydrates.
2: Placebo.: Placebo Comparator 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.
BF: No Intervention 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 parameter 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

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

Contacts

Contact: Ricardo Closa, PhD, Prof	+34977295800 ext 1463	ricardo.closa@urv.cat
Contact: Veronica Luque, Msc	+34977759365	veronica.luque@urv.cat

Locations

Spain
Hospital Universitari de Tarragona Joan XXIII	Recruiting
Tarragona, Spain, 43005
Contact: Ricardo Closa, PhD, Prof +34977295800 ext 1463 ricardo.closa@urv.cat
Contact: Veronica Luque, Msc +34977759365 veronica.luque@urv.cat
Principal Investigator: Ricardo Closa, PhD, Prof
Sub-Investigator: Veronica Luque, Msc
Spain, Tarragona
Hospital Universitari Sant Joan de Reus	Recruiting
Reus, Tarragona, Spain, 43201
Contact: Joaquin Escribano, PhD, Prof +34977310300 ext 5325 joaquin.escribano@urv.cat
Contact: Natalia Ferre, PhD +34977759365 natalia.ferre@urv.cat
Principal Investigator: Joaquin Escribano, PhD, Prof
Sub-Investigator: Natalia Ferre, PhD

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, Msc	University Rovira i Virgili

More Information

Responsible Party:	University Rovira i Virgili ( Prof. Ricardo Closa )
Study ID Numbers:	BAMBINOL
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808756
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by University Rovira i Virgili:

Carbohydrates
Infant
Intestine

Faeces
Growth
Diet

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 14, 2009