Formula Tolerance of Term Infants

Not Applicable

Completed

• Conditions: Gastro-Intestinal Tolerance
• Interventions: Other: Study Infant Formula

• Registration Number: NCT04915937
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-07
• Study Start: 2021-07-13
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-22
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Infant Formula	Study Infant Formula	Feed ad libitum during study period

Primary Outcome Measures

Name	Time	Method
Fussiness	Baseline to Study Day (SDAY) 2	Absolute and % change in fussiness severity reported from Daily Tolerance Diary

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Tolerance	Baseline to SDAY 28	Parent Completed Diary
Stool	Baseline to SDAY 28	Parent Completed Diary

Trial Locations

Locations (12)

Dade Research Center, LLC; 🇺🇸 Miami, Florida, United States

MedPharmics; 🇺🇸 Covington, Louisiana, United States

Maximos Ob/Gyn; 🇺🇸 League City, Texas, 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, LLC; 🇺🇸 Phoenix, Arizona, United States

Boeson Research Kalispell; 🇺🇸 Kalispell, Montana, United States

AVIATI Healthcare & Clinical Research; 🇺🇸 Memphis, Tennessee, United States

Be Well Clinical Studies; 🇺🇸 Lincoln, Nebraska, United States

Meridian Clinical Research; 🇺🇸 Hastings, Nebraska, United States

Invesclinic US LLC; 🇺🇸 Edinburg, Texas, United States