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Completed

NCT Number: NCT01184378

Tolerance and Digestibility of a New Formula in Healthy Infants

The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.

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Key information

Conditions

Steatorrhea Digestive System Diseases Gastrointestinal Diseases Growth Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculté de Médecine, Dijon, France

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • normal growth;
  • considered as healthy by the investigator according to the medical interrogation and the clinical examination;
  • receiving exclusively infant formula for at least 15 days.
  • without any solid food during the month of the study

Exclusion criteria

  • Premature born children or small born weights;
  • Children breast-fed or weaned for less than 15 days;
  • Children with solid food
  • Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
  • Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
  • Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
  • Children under medical treatment (ex: paracetamol).

Treatment and study plan

dairy lipids and soluble milk proteins

Dietary Supplement

one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake

Primary outcomes

  1. digestibility of lipids in formula

    Time frame: during the 30d consumption period

    lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake

Secondary outcomes

  1. tolerance and growth

    Time frame: during the 30d of formula intake

Sponsors and collaborators

Lead sponsor

Lactalis

Industry

Registry information

Official study title

Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 18, 2010
Registry last updated
Jan 26, 2011

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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