Tolerance of Infants Fed a Hydrolysate Formula

Not Applicable

Completed

• Conditions: Gastrointestinal Tolerance
• Interventions: Other: Hydrolysate Infant Formula 1; Other: Hydrolysate Infant Formula 2

• Registration Number: NCT03628183
• Lead Sponsor: Abbott Nutrition

Brief Summary

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Study Start: 2018-08-28
• Primary Completion: 2018-11-23
• Study Completion: 2018-11-23
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Subject is judged to be in good health
• Singleton from a full-term birth
• Birth weight was > or = to 2490 g
• Between 0 and 14 days of age at enrollment
• Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study
• Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion Criteria

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
• Subject participates in another study that has not been approved as a concomitant study
• Subject has an allergy or intolerance to any ingredient in the study product
• Subject has been treated with antibiotics within 2 weeks prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydrolysate Infant Formula 1	Hydrolysate Infant Formula 1	Ready to feed infant formula in can
Hydrolysate Infant Formula 2	Hydrolysate Infant Formula 2	Ready to feed infant formula in bottle

Primary Outcome Measures

Name	Time	Method
Stool Characteristics	Study Day 1 - Study Day 21	Parent completed diary

Secondary Outcome Measures

Name	Time	Method
Length	Study Day 1 - Study Day 21	Length board
Formula Intake	Study Day 1 - Study Day 21	Parent completed diary
Weight	Study Day 1 - Study Day 21	Scale

Trial Locations

Locations (5)

Springs Medical Research; 🇺🇸 Owensboro, Kentucky, United States

Watching Over Mothers and Babies; 🇺🇸 Tucson, Arizona, United States

Institute of Clinical Research, LLC; 🇺🇸 Mentor, Ohio, United States

The Cleveland Pediatric Research Center, LLC; 🇺🇸 Cleveland, Ohio, United States

Midsouth Center for Clinical Research; 🇺🇸 Memphis, Tennessee, United States