Behavior of Infants Fed Formula Supplemented With Prebiotics

Gastrointestinal Tolerance Clinical Trial

Official title:

Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757924
• Other study ID #: AL20
• Status: Completed
• Phase: N/A
• First received: April 28, 2016
• Last updated: June 16, 2017
• Start date: May 2016
• Est. completion date: May 2, 2017

Study information

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

Clinical Trial Summary

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 42 Days

Eligibility

Inclusion Criteria:

• Subject is judged to be in good health.

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

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

• Infant was identified by parents as very fussy or extremely fussy.

• Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product 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:

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.

• Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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 prebiotics
Sole source nutrition

Locations

Country	Name	City	State
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Holston Medical Group	Bristol	Tennessee
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Aventiv Research	Grove City	Ohio
United States	Holston Medical Group	Kingsport	Tennessee
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Pensacola Research Consultants, Inc	Pensacola	Florida
United States	Score Physician Alliance, LLC	Saint Petersburg	Florida
United States	Southwest Children's Research Associates, P.A.	San Antonio	Texas

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 study day 1) to within 1 day of initiation of study feeding
Secondary	Fussiness	Parent Questionnaires	Baseline to Day 29
Secondary	Hours of Daily Crying	Parent Questionnaires	Baseline to Day 29
Secondary	Gastrointestinal Tolerance	Parent Questionnaires	Baseline to Day 29
Secondary	Stool Pattern	Parent Questionnaires	Baseline to Day 29