Acceptance Of A Partially-Hydrolyzed Infant Formula

Stool Clinical Trial

Official title:

Acceptance Of A Partially-Hydrolyzed Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223792
• Other study ID #: 3389-1
• Status: Completed
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 300 Days

Eligibility

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

Related Conditions & MeSH terms

• Stool

Intervention

Other:
• Control
Routine cow's milk-based infant formula
• Investigational
Partially-hydrolyzed cow's milk protein infant formula

Locations

Country	Name	City	State
United States	Kentucky Pediatrics/Adult Research	Bardstown	Kentucky
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Deaconess Clinical Research	Evansville	Indiana
United States	Northwest Arkansas Pediatric Clinic	Fayetteville	Arkansas
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Deaconess Clinic	Newburgh	Indiana
United States	Owensboro Pediatrics	Owensboro	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency measured by MJN stool consistency scale		14 days
Secondary	Stool frequency		14 days
Secondary	Formula acceptance measured by intake diary		14 days
Secondary	Formula gastrointestinal tolerance measured by diary		14 days
Secondary	Bowel movement characteristics by diary		14 days
Secondary	Medically confirmed adverse events throughout the study period		14 days