Formula Tolerance of Term Infants

December 19, 2022 updated by: Abbott Nutrition

Tolerance of Term Infants Fed Formula With Oligosaccharides

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC
    • Florida
      • Miami, Florida, United States, 33126
        • Dade Research Center, LLC
    • Georgia
      • Macon, Georgia, United States, 31210
        • Meridian Clincial Research- Macan
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Springs Medical Research
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • MedPharmics
    • Montana
      • Kalispell, Montana, United States, 59901
        • Boeson Research Kalispell
    • Nebraska
      • Hastings, Nebraska, United States, 68901
        • Meridian Clinical Research
      • Lincoln, Nebraska, United States, 68516
        • Be Well Clinical Studies
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • AVIATI Healthcare & Clinical Research
    • Texas
      • Edinburg, Texas, United States, 78539
        • Invesclinic US LLC
      • League City, Texas, United States, 77573
        • Maximos Ob/Gyn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Infant Formula
Feed ad libitum during study period
Other: Study Infant Formula
RTF milk-based infant formula with oligosaccharides

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fussiness
Time Frame: Baseline to Study Day (SDAY) 2
Absolute and % change in fussiness severity reported from Daily Tolerance Diary
Baseline to Study Day (SDAY) 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Tolerance
Time Frame: Baseline to SDAY 28
Parent Completed Diary
Baseline to SDAY 28
Stool
Time Frame: Baseline to SDAY 28
Parent Completed Diary
Baseline to SDAY 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Formula Intake
Time Frame: SDAY 1 to SDAY 28
Parent Completed Diary
SDAY 1 to SDAY 28
Weight
Time Frame: SDAY 1 to SDAY 28
Weight gains, percentiles, and z-scores
SDAY 1 to SDAY 28
Length
Time Frame: SDAY 1 to SDAY 28
Length gains, percentiles, and z-scores
SDAY 1 to SDAY 28
Infant Feeding and Stool Patterns Questionnaire
Time Frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 16, 5-point Likert scale questions, scaled from frequent to less frequent
SDAY 1 and SDAY 28
Formula Satisfaction Questionnaire
Time Frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 13 questions of up to 5 categories scaled from positive to negative
SDAY 1 and SDAY 28
Parental perspectives
Time Frame: SDAY 1 and SDAY 28
Parent completed questionnaire; 4, 5-point Likert scale questions, scaled from negative to positive
SDAY 1 and SDAY 28
Health Resource Utilization
Time Frame: SDAY 7 and SDAY 28
Number of Visits
SDAY 7 and SDAY 28
Adverse Events
Time Frame: SDAY 1 to SDAY 28
Standard adverse event reporting
SDAY 1 to SDAY 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Elizabeth Reverri, PhD, MS, RD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AL41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings