Effect of Formula on Infant Behavior

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-31

Brief Summary

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

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Related Clinical Trials

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

Behavior of Infants Fed Formula Supplemented With Prebiotics

NCT02757924

Gastrointestinal Tolerance

COMPLETED NA

Formula Tolerance of Term Infants

NCT04915937

Gastro-Intestinal Tolerance

COMPLETED NA

Growth and Tolerance of Young Infants Fed Infant Formula

NCT04105686

Growth and Tolerance

COMPLETED NA

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964

Gastrointestinal Tolerance

COMPLETED PHASE3

Tolerance of Healthy Term Infants Fed Infant Formulas

NCT00705562

Infant, Newborn

COMPLETED PHASE2

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.

Gastrointestinal Tolerance

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Infant Formula supplemented with Oligosaccharides

Ready to feed infant formula ; Feed ad libitum.

Group Type EXPERIMENTAL

Infant Formula supplemented with Oligosaccharides

Intervention Type OTHER

sole source nutrition

Interventions

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

Infant Formula supplemented with Oligosaccharides

sole source nutrition

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Subject is in good health as determined from subject's medical history by parent report
* Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
* Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* Subject is between 7 and 42 days of age
* Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
* Infant is exclusively formula-fed at time of study entry
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
* Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria

* An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
* Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Subject participates in another study that has not been approved as a concomitant study
* Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
* Subject has been treated with oral antibiotics within 7 days prior to study enrollment
* Mother intends to use a combination of breast and formula feeding

Minimum Eligible Age

7 Days

Maximum Eligible Age

42 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes