Gastrointestinal Tolerance Evaluation of an Infant Formula

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

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2018-01-19

Brief Summary

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Prospective, double-blind, randomized study of 2 infant formulas.

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Detailed Description

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Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.

Conditions

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Healthy, Full-term Infants Who Are Formula-fed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Routine Infant Formula 1

Routine infant formula with probiotic

Group Type ACTIVE_COMPARATOR

Routine Infant Formula 1

Intervention Type OTHER

Routine infant formula with probiotic

Routine Infant Formula 2

Routine infant formula with probiotic and prebiotic

Group Type ACTIVE_COMPARATOR

Routine Infant Formula 2

Intervention Type OTHER

Routine infant formula with probiotic and prebiotic

Interventions

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Routine Infant Formula 1

Routine infant formula with probiotic

Intervention Type OTHER

Routine Infant Formula 2

Routine infant formula with probiotic and prebiotic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy newborn singleton infant
* Full-term (\> 37 weeks gestation)
* Birth weight ≥ 2500 grams and ≤ 4500 grams
* 9-19 days of age on enrollment
* Infant's mother has elected not to breastfeed prior to enrollment and infant has exclusively formula-fed for at least 3days prior to enrollment
* Having obtained his/her legal representative's informed consent

Exclusion Criteria

* Known or suspected cow-milk allergy
* Currently receiving a specialty infant formula (e.g. extensively hydrolyzed, amino acid-based, metabolic), or soy-based or lactose free infant formula
* Currently not tolerating (as perceived by the caregiver) their formula
* Currently being treated for reflux
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an on-going infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)
* Congenital illness or malformation that may affect infant feeding and/or growth
* Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment
* Receiving prescription medication (with exception of treatment for thrush or topical medications) or home remedies, herbal preparations, or rehydration fluids that might affect GI tolerance (vitamin and mineral supplements excepted).
* Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).
* Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Minimum Eligible Age

9 Days

Maximum Eligible Age

19 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes