Formula Tolerance of Term Infants

NCT04915937 | Completed

• 1 other identifier: AL41
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Gastro-Intestinal Tolerance

Outcome Measures

Primary Outcomes (1)

• Fussiness

  Absolute and % change in fussiness severity reported from Daily Tolerance Diary

  Baseline to Study Day (SDAY) 2

Secondary Outcomes (2)

• Gastrointestinal Tolerance

  Baseline to SDAY 28

• Stool

  Baseline to SDAY 28

Other Outcomes (8)

• Formula Intake

  SDAY 1 to SDAY 28

• Weight

  SDAY 1 to SDAY 28

• Length

  SDAY 1 to SDAY 28

Study Arms (1)

Study Infant Formula

EXPERIMENTAL

Feed ad libitum during study period

Other: Study Infant Formula

Interventions

Study Infant Formula OTHER

RTF milk-based infant formula with oligosaccharides

Study Infant Formula

Eligibility Criteria

• Age: 7 Days - 65 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (12)

MedPharmics, LLC

Phoenix, Arizona, 85015, United States

Location

Dade Research Center, LLC

Miami, Florida, 33126, United States

Location

Meridian Clincial Research- Macan

Macon, Georgia, 31210, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

MedPharmics

Covington, Louisiana, 70433, United States

Location

Boeson Research Kalispell

Kalispell, Montana, 59901, United States

Location

Meridian Clinical Research

Hastings, Nebraska, 68901, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 68516, United States

Location

AVIATI Healthcare & Clinical Research

Memphis, Tennessee, 38115, United States

Location

Invesclinic US LLC

Edinburg, Texas, 78539, United States

Location

Maximos Ob/Gyn

League City, Texas, 77573, United States

Location

Study Officials

• Elizabeth Reverri, PhD, MS, RD

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: July 13, 2021
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)