Gastrointestinal Tolerance Clinical Trial
Official title:
Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics
Verified date | June 2017 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
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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