Effect of Formula on Infant Behavior

Gastrointestinal Tolerance Clinical Trial

Official title:

Effect of Formula Supplemented With Oligosaccharides on Infant Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746016
• Other study ID #: AL19
• Status: Completed
• Phase: N/A
• First received: April 13, 2016
• Last updated: March 28, 2017
• Start date: April 2016
• Est. completion date: October 2016

Study information

• Verified date: March 2017
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 42 Days

Eligibility

Inclusion Criteria:

• Subject is in good health as determined from subject's medical history by parent report

• Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks

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

• Subject is between 7 and 42 days of age

• Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation

• Infant is exclusively formula-fed at time of study entry

• 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

• Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

Exclusion Criteria:

• An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development

• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance

• Subject participates in another study that has not been approved as a concomitant study

• Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment

• Subject has been treated with oral antibiotics within 7 days prior to study enrollment

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

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Infant Formula supplemented with Oligosaccharides
sole source nutrition

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Institute of Clinical Research, LLC	Cleveland	Ohio
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Aventiv Research	Grove City	Ohio
United States	Tanner Clinic	Layton	Utah
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Norwich Pediatric Group, PC	Norwich	Connecticut
United States	Florida Institute for Clinical Research, LLC	Orlando	Florida
United States	Score Physician Alliance, LLC	Saint Petersburg	Florida
United States	Southwest Children's Research Associates, P.A.	San Antonio	Texas
United States	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	Fussiness	Parent Questionnaires	Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Secondary	Fussiness	Parent Questionnaires	Baseline to SDAY 29
Secondary	Hours of daily crying	Parent Questionnaires	Baseline to SDAY 29
Secondary	Gastrointestinal Tolerance	Parent Questionnaires	Baseline to SDAY 29
Secondary	Stool Pattern	Parent Questionnaire	Baseline to SDAY 29