Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
Phase 3
Completed
- Conditions
- InfantGastrointestinal Intolerance
- Registration Number
- NCT01573871
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Infant is 0 to 180 days of age
- Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
- Infant has not consumed an extensively hydrolyzed infant formula
- Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
- Infant is not receiving steroids.
- 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 solid foods or juices to their infant through the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral during the study
Exclusion Criteria
• Participation in another study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Weight maintenance 14 days
- Secondary Outcome Measures
Name Time Method Formula volume intake 14 days
Trial Locations
- Locations (3)
Northpoint Pediatrics
🇺🇸Indianapolis, Indiana, United States
Metro-Health Medical Center
🇺🇸Cleveland, Ohio, United States
Ohio Pediatric Research Association
🇺🇸Huber Heights, Ohio, United States
Northpoint Pediatrics🇺🇸Indianapolis, Indiana, United States