Tolerance of Infants Fed a Hydrolysate Formula
Not Applicable
Completed
- Conditions
- Gastrointestinal Tolerance
- Registration Number
- NCT03628183
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Subject is judged to be in good health
- Singleton from a full-term birth
- Birth weight was > or = to 2490 g
- Between 0 and 14 days of age at enrollment
- Parent(s) confirm their intention to feed their infant the assigned 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
- Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
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, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant study
- Subject has an allergy or intolerance to any ingredient in the study product
- Subject has been treated with antibiotics within 2 weeks prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stool Characteristics Study Day 1 - Study Day 21 Parent completed diary
- Secondary Outcome Measures
Name Time Method Length Study Day 1 - Study Day 21 Length board
Formula Intake Study Day 1 - Study Day 21 Parent completed diary
Weight Study Day 1 - Study Day 21 Scale
Trial Locations
- Locations (5)
Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States
The Cleveland Pediatric Research Center, LLC
🇺🇸Cleveland, Ohio, United States
Institute of Clinical Research, LLC
🇺🇸Mentor, Ohio, United States
Midsouth Center for Clinical Research
🇺🇸Memphis, Tennessee, United States
Watching Over Mothers and Babies🇺🇸Tucson, Arizona, United States