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Tolerance of Healthy Infants Fed Infant Formulas | Clinical Trials | Clareo Health

COMPLETEDNA

Tolerance of Healthy Infants Fed Infant Formulas

NCT02401217•Abbott Nutrition

Summary

The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Singleton from a full term birth with a gestational age of 37-42 weeks.
•Birth weight was \> 2490 g (\~5 lbs 8 oz).
•Age between 0 and 30 days at enrollment.
•Agreement to discontinue the use of medications (including over the counter \[OTC\], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
•Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
•Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
•Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) 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 infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
•Infant treated with antibiotics.
•Participation in another study that has not been approved as a concomitant study by AN.

Locations (6)

W.O.M.B Watching Over Mothers and Babies

Tucson, Arizona, United States

SCORE Physician Alliance LLC

St. Petersburg, Florida, United States

White Oak Family Physicians DBA/Asheboro Research Associates

Asheboro, North Carolina, United States

Institute of Clinical Research, LLC

Mayfield Heights, Ohio, United States

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, United States

Tanner Memorial Clinic

Layton, Utah, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

January 12, 2016

Enrollment

126

ACTUAL participants

Conditions

Gastrointestinal Tolerance

Interventions

Phase 1- Arm 1 Infant Formula

OTHER

Phase 2- Arm 2 Infant Formula

OTHER

Phase 2- Arm 3 Infant Formula

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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