Gastrointestinal Tolerance of Infant Formula
- Conditions
- Gastrointestinal Tolerance
- Registration Number
- NCT02322138
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
- Infant is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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.
- Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
- Mother intends to use a combination of breast and formula feeding.
- Participation in another study that has not been approved as a concomitant study by AN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stool Consistency Questionnaire Baseline to 35 Days of Age Questionnaire
- Secondary Outcome Measures
Name Time Method Head Circumference Baseline to 35 Days of Age Measured
Stools per Day Questionnaire Baseline to 35 Days of Age Questionnaire
Feeding Spit Up Questionnaire Baseline to 35 Days of Age Questionnaire
Weight Baseline to 35 Days of Age Measured
Length Baseline to 35 Days of Age Measured
Trial Locations
- Locations (10)
W.O.M.B Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
Clinical Research Advantage/Colorado Springs Health Partners
🇺🇸Colorado Springs, Colorado, United States
Norwich Pediatric Group, PC
🇺🇸Norwich, Connecticut, United States
SCORE Physician Alliance, LLC
🇺🇸St. Petersburg, Florida, United States
Michael W. Simon, M.D., PSC
🇺🇸Nicholasville, Kentucky, United States
Women's Clinic of Lincoln, PC.
🇺🇸Lincoln, Nebraska, United States
White Oak Family Physicians DBA Asheboro Research Associates
🇺🇸Asheboro, North Carolina, United States
Institute of Clinical Research
🇺🇸Mayfield Heights,, Ohio, United States
The Cleveland Pediatric Research Center, LLC
🇺🇸Middleburg Heights, Ohio, United States
Tanner Memorial Clinic
🇺🇸Layton, Utah, United States
W.O.M.B Watching Over Mothers and Babies🇺🇸Tucson, Arizona, United States