Tolerance of Healthy Term Infants Fed Infant Formulas #4

Healthy Term Infants Clinical Trial

Official title:

Tolerance of Healthy Term Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155414
• Other study ID #: AK75
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2010
• Last updated: October 31, 2011
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

Inclusion Criteria:

• Singleton full term birth in good health

• Birth weight was > 2490 g.

• Between 0 and 8 days of age.

• Infants using 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 may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.

• 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 or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

Exclusion Criteria:

• An adverse maternal, fetal or infant medical history and treatment with antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Term Infants

Intervention

Other:
• Hydrolysate based infant formula
Infant formula ad lib
• Investigational Infant Formula A
Investigational infant formula ad lib
• Investigational Infant Formula B
Investigational infant formula ad lib

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University of Iowa	Coralville	Iowa
United States	Alabama Clinical Therapeutics, LLC	Dothan	Alabama
United States	Medical Associates Clinic, PC	Dubuque	Iowa
United States	Pediatric Clinical Research Office	Hershey	Pennsylvania
United States	Ohio Pediatric Research Association	Huber Heights	Ohio
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Institute of Clinical Research	Mayfield Heights	Ohio
United States	SCORE Physician Alliance	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI tolerance via stool consistency		28 days	No