Gastrointestinal Tolerance Clinical Trial
Official title:
Tolerance of Healthy Term Infants Fed Infant Formulas
Verified date | November 2010 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
Status | Completed |
Enrollment | 270 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
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. - Infant's birth weight was > 2490 g (~5 lbs 8 oz. - Infant is between 0 and 8 days of age at enrollment. - Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled. - 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, unless instructed otherwise by their healthcare professional. Exclusion Criteria: - An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. - Infant has been treated with antibiotics. - Infant has received probiotics. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kentucky Pediatric / Adult Research | Bardstown | Kentucky |
United States | Pediatric Associates of Mount Carmel, Inc | Cincinnati | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | North Georgia Clinical Research | Dalton | Georgia |
United States | Dayton Clinical Research | Dayton | Ohio |
United States | Alabama Clinical Therapeutics | Dothan | Alabama |
United States | Medical Associates Clinic, PC | Dubuque | Iowa |
United States | Ohio Pediatric Research Association, Inc. | Huber Heights | Ohio |
United States | Northpoint Pediatrics, LLC | Indianapolis | Indiana |
United States | The Jackson Clinic, PA | Jackson | Tennessee |
United States | Institute of Clinical Research | Mayfield Heights | Ohio |
United States | All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc | Plantation | Florida |
United States | Rockwood Clinic North - Pediatrics | Spokane | Washington |
United States | SCORE Physician Alliance, LLC | St. Petersburg | Florida |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary variable is Gastrointestinal tolerance. | 1-28 days of age | No | |
Secondary | The secondary variables are additional measures of GI tolerance and parental feedback. | 1-28 days of age | No |
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