Impact of Infant Formula on Caregiver-perceived Intolerance

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2019-04-01

Brief Summary

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

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Related Clinical Trials

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

Gastrointestinal Tolerance Evaluation of an Infant Formula

NCT03307122

Healthy, Full-term Infants Who Are Formula-fed

COMPLETED NA

Behavior of Infants Fed Formula Supplemented With Prebiotics

NCT02757924

Gastrointestinal Tolerance

COMPLETED NA

Effect of Formula on Infant Behavior

NCT02746016

Gastrointestinal Tolerance

COMPLETED NA

Gastrointestinal Tolerance of Infant Formula

NCT02322138

Gastrointestinal Tolerance

COMPLETED NA

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964

Gastrointestinal Tolerance

COMPLETED PHASE3

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.

Healthy Infants

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

TREATMENT

Blinding Strategy

NONE

Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.

Study Groups

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

Intervention

Routine infant formula

Group Type EXPERIMENTAL

Routine infant formula

Intervention Type OTHER

Routine infant formula with probiotic

Interventions

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

Routine infant formula

Routine infant formula with probiotic

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Healthy infant
* Full-term (\> 37 weeks gestation)
* Birth weight \> 2500 and \< 4500 g
* 14-60 days of age on enrollment
* Singleton birth
* Infant's mother has elected not to breastfeed prior to enrollment
* Infant exclusively formula-fed for at least 5 days prior to enrollment
* Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days
* Caregiver wishes to switch infant's formula
* Has not received solid foods
* 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. thickened, extensively hydrolyzed, amino acid-based, metabolic)
* Has switched formula more than two times since hospital discharge
* Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing 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 probiotic supplements
* 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

14 Days

Maximum Eligible Age

60 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes