Acceptance Of A Partially-Hydrolyzed Infant Formula

Not Applicable

Completed

• Conditions: Stool
• Interventions: Other: Investigational; Other: Control

• Registration Number: NCT03223792
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-21
• Study Start: 2017-08-21
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Singleton 28-300 days of age at randomization
• Gestational age less than or equal to 35 weeks
• Receiving minimum 18oz infant formula in the 24hrs prior to randomization
• History of hard stools or stooling difficulty
• Signed informed consent and protected health information

Exclusion Criteria

• Current diagnosis of cow's milk protein allergy or intolerance
• Use of extensively hydrolyzed or amino acid formula at randomization
• Any abdominal or gastrointestinal surgery prior to randomization
• History of underlying metabolic or chronic disease or congenital malformation
• Organic causes of constipation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational	Investigational	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Stool consistency measured by MJN stool consistency scale	14 days

Secondary Outcome Measures

Name	Time	Method
Stool frequency	14 days
Formula acceptance measured by intake diary	14 days
Formula gastrointestinal tolerance measured by diary	14 days
Bowel movement characteristics by diary	14 days
Medically confirmed adverse events throughout the study period	14 days

Trial Locations

Locations (11)

Deaconess Clinical Research; 🇺🇸 Evansville, Indiana, United States

Northwest Arkansas Pediatric Clinic; 🇺🇸 Fayetteville, Arkansas, United States

Ohio Pediatric Research Association; 🇺🇸 Dayton, Ohio, United States

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Deaconess Clinic; 🇺🇸 Newburgh, Indiana, United States

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Southeastern Pediatric Associates; 🇺🇸 Dothan, Alabama, United States

The Children's Clinic of Jonesboro, P.A.; 🇺🇸 Jonesboro, Arkansas, United States

Kentucky Pediatrics/Adult Research; 🇺🇸 Bardstown, Kentucky, United States

Owensboro Pediatrics; 🇺🇸 Owensboro, Kentucky, United States

Coastal Pediatric Research; 🇺🇸 Charleston, South Carolina, United States