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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02757924
Other study ID # AL20
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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