Gastrointestinal Tolerance of Infant Formula

Gastrointestinal Tolerance Clinical Trial

Official title:

Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322138
• Other study ID #: AL14
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: July 22, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 8 Days

Eligibility

Inclusion Criteria:

• Infant is judged to be in good health.

• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.

• Infant's birth weight was > 2490 g (~5 lbs 8 oz.).

• Infant is between 0 and 8 days of age at enrollment.

• Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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.

Exclusion Criteria:

• Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.

• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.

• Mother intends to use a combination of breast and formula feeding.

• Participation in another study that has not been approved as a concomitant study by AN.

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Experimental 1 Infant Formula
Ready to feed infant formula to be fed ad-libitum
• Experimental 2 Infant Formula
Ready to feed infant formula to be fed ad-libitum
• Reference Group
Breast fed ad libitum

Locations

Country	Name	City	State
United States	White Oak Family Physicians DBA Asheboro Research Associates	Asheboro	North Carolina
United States	Clinical Research Advantage/Colorado Springs Health Partners	Colorado Springs	Colorado
United States	Tanner Memorial Clinic	Layton	Utah
United States	Women's Clinic of Lincoln, PC.	Lincoln	Nebraska
United States	Institute of Clinical Research	Mayfield Heights,	Ohio
United States	The Cleveland Pediatric Research Center, LLC	Middleburg Heights	Ohio
United States	Michael W. Simon, M.D., PSC	Nicholasville	Kentucky
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	SCORE Physician Alliance, LLC	St. Petersburg	Florida
United States	W.O.M.B Watching Over Mothers and Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Consistency Questionnaire	Questionnaire	Baseline to 35 Days of Age	No
Secondary	Stools per Day Questionnaire	Questionnaire	Baseline to 35 Days of Age	No
Secondary	Feeding Spit Up Questionnaire	Questionnaire	Baseline to 35 Days of Age	No
Secondary	Weight	Measured	Baseline to 35 Days of Age	No
Secondary	Length	Measured	Baseline to 35 Days of Age	No
Secondary	Head Circumference	Measured	Baseline to 35 Days of Age	No