Loading clinical trials...

Formula Tolerance of Term Infants | Clinical Trials | Clareo Health

COMPLETEDNA

Formula Tolerance of Term Infants

Tolerance of Term Infants Fed Formula With Oligosaccharides

NCT04915937•Abbott Nutrition

Summary

To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participant is judged to be in good health as determined from participant's medical history by parent report
•Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
•Participant's birth weight was \>= 2490 g (\~5 lbs. 8 oz.)
•Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
•Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
•Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition 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 applicable local 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. This includes but is not limited to suspected maternal substance abuse.
•Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
•Participant participates in another study that has not been approved as a concomitant study
•Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
•Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
•Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
•Participant has been treated with antibiotics within 7 days prior to enrollment

Locations (12)

MedPharmics, LLC

Phoenix, Arizona, United States

Dade Research Center, LLC

Miami, Florida, United States

Meridian Clincial Research- Macan

Macon, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Springs Medical Research

Owensboro, Kentucky, United States

MedPharmics

Covington, Louisiana, United States

Boeson Research Kalispell

Kalispell, Montana, United States

Meridian Clinical Research

Hastings, Nebraska, United States

Be Well Clinical Studies

Lincoln, Nebraska, United States

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, United States

Key Dates

Start Date

July 13, 2021

Primary Completion Date

November 22, 2022

Completion Date

November 22, 2022

Last Updated

December 20, 2022

Enrollment

ACTUAL participants

Conditions

Gastro-Intestinal Tolerance

Interventions

Study Infant Formula

OTHER

Gastrointestinal Tolerance of a Nutritional Supplement in Adult Patients With or at Risk of Malnutrition

NCT04259437

Gastro-Intestinal Tolerance

View study

WITHDRAWNNA

GI Tolerance and Acceptability of a New Thickener

NCT04104815

Gastro-intestinal Tolerance

View study

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: December 20, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions