FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

A Study to Monitor the Use of an Amino Acid-Based Infant Formula

Study Purpose

To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational [Patient Registry]
Eligible Ages N/A - 12 Months
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Infants who use a free amino acid based Infant formula during their first year of life including: - Those that are currently consuming the formula at the time of enrollment - Those for whom consumption of the formula is planned - At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program

Exclusion Criteria:

- Infants <37 weeks of corrected gestation age (CGA) at time of enrollment

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02953223

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Nestlé

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Juan Ochoa, MD
Principal Investigator Affiliation Nestle Health Science

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Active, not recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome, Multiple Food Allergies
Additional Details

Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pediatric Multicare West, Lakeside, Arizona

Status

Address

Pediatric Multicare West

Lakeside, Arizona, 85929

Phoenix Children's Hospital, Phoenix, Arizona

Status

Address

Phoenix Children's Hospital

Phoenix, Arizona, 85016

University of Arizona, Tucson, Arizona

Status

Address

University of Arizona

Tucson, Arizona, 85724

Applied Research Center of Arkansas, Little Rock, Arkansas

Status

Address

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212

Sutter Institute of Medical Research, Roseville, California

Status

Address

Sutter Institute of Medical Research

Roseville, California, 95816

Pioneer Clinical Research, Coconut Creek, Florida

Status

Address

Pioneer Clinical Research

Coconut Creek, Florida, 33066

Children's Center for GI and Nutrition, Hollywood, Florida

Status

Address

Children's Center for GI and Nutrition

Hollywood, Florida, 33021

Childerns Health Center, PA, Homestead, Florida

Status

Address

Childerns Health Center, PA

Homestead, Florida, 33030

Homestead Medical Clinic, Miami, Florida

Status

Address

Homestead Medical Clinic

Miami, Florida, 33030

Next Phase Research, Virginia Gardens, Florida

Status

Address

Next Phase Research

Virginia Gardens, Florida, 33166

Children's Gastroenterology Speciality, Glenview, Illinois

Status

Address

Children's Gastroenterology Speciality

Glenview, Illinois, 60026

Childrens Health Care, Wheeling, Illinois

Status

Address

Childrens Health Care

Wheeling, Illinois, 60090

Springs Medical Research, Owensboro, Kentucky

Status

Address

Springs Medical Research

Owensboro, Kentucky, 42303

Acadiana Pediatric Gastro and Hep, Lafayette, Louisiana

Status

Address

Acadiana Pediatric Gastro and Hep

Lafayette, Louisiana, 70508

Tulane University Health Sciences Center, Metairie, Louisiana

Status

Address

Tulane University Health Sciences Center

Metairie, Louisiana, 70001

Conduct Clinical Trials, Flushing, New York

Status

Address

Conduct Clinical Trials

Flushing, New York, 11367

Great Neck, New York

Status

Address

The Feinstein Institute for Medical Research

Great Neck, New York, 11021

State University of New York (SUNY), Syracuse, New York

Status

Address

State University of New York (SUNY)

Syracuse, New York, 13210

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina, 27705

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

UH Rainbow Babies & Children's Hospital, Cleveland, Ohio

Status

Address

UH Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106

Oklahoma City, Oklahoma

Status

Address

University of Oklahoma, Health Sciences Center

Oklahoma City, Oklahoma, 73104

Milestones Pediatric Care, Tulsa, Oklahoma

Status

Address

Milestones Pediatric Care

Tulsa, Oklahoma, 74146

Cyn3rgy Research, Gresham, Oregon

Status

Address

Cyn3rgy Research

Gresham, Oregon, 97030

Invocare Clinical Research Center, West Columbia, South Carolina

Status

Address

Invocare Clinical Research Center

West Columbia, South Carolina, 29169

Childrens Health Center, PA, Marble Falls, Texas

Status

Address

Childrens Health Center, PA

Marble Falls, Texas, 78654

San Antonio, Texas

Status

Address

Southwest Children's Research Assoicaites

San Antonio, Texas, 78229

Dixie Pediatrics, Saint George, Utah

Status

Address

Dixie Pediatrics

Saint George, Utah, 84790

Tacoma, Washington

Status

Address

Multicare Institute for research and Innovation

Tacoma, Washington, 98405

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.