Nutritive Effects of Prebiotics on Early Postnatal Behavioral Measures of Tolerance

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is intended to measure infant comfort, behavior, and sleep when consuming study formula with prebiotics compared to infants who consume a study formula without the prebiotics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gastrointestinal Tolerance of Infant Formula

NCT02322138

Gastrointestinal Tolerance

COMPLETED NA

Behavior of Infants Fed Formula Supplemented With Prebiotics

NCT02757924

Gastrointestinal Tolerance

COMPLETED NA

Exploratory/Proof of Principle Microbiota Study

NCT02500563

Fecal Microbiota

COMPLETED NA

Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil

NCT01177605

Gastrointestinal Problems

COMPLETED NA

The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

NCT01897922

Growth of Term Infants

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Behavioral Measures of Tolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Previously marketed cow's milk-based infant formula

Group Type ACTIVE_COMPARATOR

Previously marketed cow's mlik-based infant formula

Intervention Type OTHER

Marketed cow's milk-based infant formula with prebiotics

Group Type EXPERIMENTAL

Marketed cow's milk-based infant formula with prebiotics

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Previously marketed cow's mlik-based infant formula

Intervention Type OTHER

Marketed cow's milk-based infant formula with prebiotics

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Singleton, 14-35 days of age at baseline
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula-fed
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria

* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Feeding difficulties or formula intolerance
* Maternal history of illicit drug use or psychiatric disease

Minimum Eligible Age

14 Days

Maximum Eligible Age

35 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes