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Tolerance and Digestibility of a New Formula in Healthy Infants

Primary Purpose

Steatorrhea, Growth

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
dairy lipids and soluble milk proteins
Sponsored by
Lactalis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Steatorrhea focused on measuring infant formula, dairy fat, soluble milk protein

Eligibility Criteria

2 Months - 4 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Faculté de Médecine
  • Hopital Mère-Enfants

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control formula

new formula

Arm Description

formula containing only vegetable fats

new formula with dairy lipids and soluble milk proteins

Outcomes

Primary Outcome Measures

digestibility of lipids in formula
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

Full Information

First Posted
August 17, 2010
Last Updated
January 25, 2011
Sponsor
Lactalis
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1. Study Identification

Unique Protocol Identification Number
NCT01184378
Brief Title
Tolerance and Digestibility of a New Formula in Healthy Infants
Official Title
Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lactalis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steatorrhea, Growth
Keywords
infant formula, dairy fat, soluble milk protein

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control formula
Arm Type
Placebo Comparator
Arm Description
formula containing only vegetable fats
Arm Title
new formula
Arm Type
Experimental
Arm Description
new formula with dairy lipids and soluble milk proteins
Intervention Type
Dietary Supplement
Intervention Name(s)
dairy lipids and soluble milk proteins
Intervention Description
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
Primary Outcome Measure Information:
Title
digestibility of lipids in formula
Description
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
Time Frame
during the 30d consumption period
Secondary Outcome Measure Information:
Title
tolerance and growth
Time Frame
during the 30d of formula intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Facility Information:
Facility Name
Faculté de Médecine
City
Dijon
ZIP/Postal Code
21078
Country
France
Facility Name
Hopital Mère-Enfants
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

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