Tolerance and Digestibility of a New Formula in Healthy Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Steatorrhea Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control formula

formula containing only vegetable fats

Group Type PLACEBO_COMPARATOR

dairy lipids and soluble milk proteins

Intervention Type DIETARY_SUPPLEMENT

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

new formula

new formula with dairy lipids and soluble milk proteins

Group Type EXPERIMENTAL

dairy lipids and soluble milk proteins

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

2 Months

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes