NCT00808756|CompletedDMC
Study on Fermentable Carbohydrates in Healthy Infants
BAMBINOL
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BAMBINOL
Sponsor study identifier
interventional
388
1 country
2
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
March 2012
Actual (reported)The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 15, 2008
Actual (reported)December 16, 2008
Actual (reported)September 2010
Actual (reported)March 2012
Actual (reported)Children well-being and appropriate growth
up to 4 months
Secondary outcomes will be metabolic parameters.
Up to 4 months
This group will be fed a diet enriched with fermentable carbohydrates.
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).
The 2 intervention groups will be compared with a breast-fed infants control group.
Infant formula enriched with fermentable carbohydrates.
Standard infant formula.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201, Spain
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, 43005, Spain
Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.
Ricardo Closa, PhD, Prof
University Rovira i Virgili & Hospital Universitari Joan XXIII
Joaquin Escribano, PhD, Prof
Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.
Veronica Luque, PhD
University Rovira i Virgili
388 participants (actual enrollment reported by the registry).
First Submitted
December 15, 2008
First Posted
December 16, 2008
Study Start
September 2008
Date type not reportedThis date has not been verified as actual or estimated.
A Neurocognitive and Immunological Study of a New Formula for Healthy Infants
Contact the study team to confirm eligibility.
Primary Completion
September 2010
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
August 8, 2012
Record last verified: 2012-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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