Healthy Term Infants Fed Milk-Based 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

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-12

Study Completion Date

2021-06-18

Brief Summary

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

This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein infant formulas.

Related Clinical Trials

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

Tolerance of Healthy Term Infants Fed Infant Formulas

NCT00705562

Infant, Newborn

COMPLETED PHASE2

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964

Gastrointestinal Tolerance

COMPLETED PHASE3

Growth and Tolerance of Infants Fed Milk-Based Infant Formula

NCT03967132

Gastro-Intestinal Tolerance

COMPLETED NA

Growth and Tolerance of Young Infants Fed Infant Formula

NCT04105686

Growth and Tolerance

COMPLETED NA

Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula

NCT04934397

Gastro-Intestinal Tolerance

TERMINATED 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.

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

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Control Infant Formula

Feed ad libitum

Group Type ACTIVE_COMPARATOR

Control Infant Formula

Intervention Type OTHER

Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide

Experimental Infant Formula

Feed ad libitum

Group Type EXPERIMENTAL

Experimental Infant Formula

Intervention Type OTHER

Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

Interventions

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

Control Infant Formula

Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide

Intervention Type OTHER

Experimental Infant Formula

Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Good health as determined from participant's medical history
* Singleton from a full-term birth with a gestational age of 37-42 weeks
* Birth weight was \> 2490 g (\~5 lbs. 8 oz.)
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
* Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study

Exclusion Criteria

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
* Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Participant is enrolled in another study that has not been approved as a concomitant study

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes