Study in Unsettled Infants Experiencing Feeding 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

259 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-12

Study Completion Date

2016-08-23

Brief Summary

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

Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Related Clinical Trials

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

Gastrointestinal Tolerance Study of a New Infant Formula

NCT01681355

Healthy Infants

COMPLETED NA

Feeding Intolerance in Formula-Fed Infants

NCT02028156

Feeding Intolerance

TERMINATED NA

Gastrointestinal Tolerance Evaluation of an Infant Formula

NCT03307122

Healthy, Full-term Infants Who Are Formula-fed

COMPLETED NA

Tolerance of Healthy Infants Fed Infant Formulas

NCT02401217

Gastrointestinal Tolerance

COMPLETED NA

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.

The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Conditions

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

Feeding Disorder

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

TREATMENT

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.

Experimental Formula

Group Type EXPERIMENTAL

Experimental Formula

Intervention Type OTHER

Experimental formula

Standard Formula

Standard Control formula

Group Type OTHER

Standard control formula

Intervention Type OTHER

Standard Infant formula

Interventions

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

Experimental Formula

Experimental formula

Intervention Type OTHER

Standard control formula

Standard Infant formula

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. Full term infants, singleton, healthy at birth
2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria

1. Infants who are consuming any amount of supplemental human milk
2. Infants who are consuming weaning foods or beverages other than infant formula
3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance
5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Minimum Eligible Age

30 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes