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Tolerance and Digestibility of a New Formula in Healthy Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01184378
First Posted: August 18, 2010
Last Update Posted: January 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lactalis
  Purpose
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.

Condition Intervention Phase
Steatorrhea Growth Dietary Supplement: dairy lipids and soluble milk proteins Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants

Further study details as provided by Lactalis:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • tolerance and growth [ Time Frame: during the 30d of formula intake ]

Estimated Enrollment: 100
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control formula
formula containing only vegetable fats
Dietary Supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Experimental: new formula
new formula with dairy lipids and soluble milk proteins
Dietary Supplement: dairy lipids and soluble milk proteins
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Months to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01184378


Locations
France
Faculté de Médecine
Dijon, France, 21078
Hopital Mère-Enfants
Rennes, France, 35000
Sponsors and Collaborators
Lactalis
  More Information

Responsible Party: Pascale le Ruyet PhD, Lactalis RetD
ClinicalTrials.gov Identifier: NCT01184378     History of Changes
Other Study ID Numbers: LRD-08-15
First Submitted: August 17, 2010
First Posted: August 18, 2010
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by Lactalis:
infant formula
dairy fat
soluble milk protein

Additional relevant MeSH terms:
Steatorrhea
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases