Assessing Early Behavioral Indicators of Formula Tolerance

Tolerance Clinical Trial

Official title:

Assessing Early Behavioral Indicators of Formula Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340143
• Other study ID #: 6025
• Status: Completed
• Phase: N/A
• First received: January 6, 2015
• Last updated: September 13, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• Singleton at birth

• Term infant with birth weight of 2500 g or more

• Crying or fussing for 3 or more hours per day

• Consuming mostly infant formula

• Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

• Current use of extensively hydrolyzed or amino acid infant formula

• Planned use of probiotics during the study

• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised

• Enrollment in another interventional clinical research study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Tolerance

Intervention

Other:
• Control
Marketed partially hydrolyzed cow's milk protein infant formula
• Investigational
Partially hydrolyzed cow's milk protein infant formula with a probiotic

Locations

Country	Name	City	State
United States	Children's Nutrition Research Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Behavior Diary		21 Days	No
Secondary	Recall of Tolerance Questionnaire		Baseline and Day 21	No
Secondary	Body Weight		Baseline and Day 21	No
Secondary	Infant Behavior Questionnaire - Revised		Baseline and Day 21	No
Secondary	Recall of formula intake at each visit		Baseline, Day 10, and Day 18	No
Secondary	Fecal microbiome and Fecal calprotectin		Baseline and Day 21	No
Secondary	Medically-confirmed Adverse Events		21 Days	No