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Completed

NCT Number: NCT00808756

Study on Fermentable Carbohydrates in Healthy Infants

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

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Key information

Conditions

Infant Growth Healthy Nutrition

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermentable carbohydrates.

Dietary Supplement

Infant formula enriched with fermentable carbohydrates.

Standard infant formula.

Other

Standard infant formula.

Primary outcomes

  1. Children well-being and appropriate growth

    Time frame: up to 4 months

Secondary outcomes

  1. Secondary outcomes will be metabolic parameters.

    Time frame: Up to 4 months

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

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

Registry information

Acronym: BAMBINOL

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Dec 16, 2008
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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