Assessing Early Behavioral Indicators of Formula Tolerance
Not Applicable
Completed
- Conditions
- Tolerance
- Interventions
- Other: ControlOther: Investigational
- Registration Number
- NCT02340143
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
- Singleton at birth
- Term infant with birth weight of 2500 g or more
- Crying or fussing for 3 or more hours per day
- Consuming mostly infant formula
- Signed Informed Consent and Protected Health Information authorization
Exclusion Criteria
- Current use of extensively hydrolyzed or amino acid infant formula
- Planned use of probiotics during the study
- History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- Enrollment in another interventional clinical research study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control Marketed partially hydrolyzed cow's milk protein infant formula Investigational Investigational Partially hydrolyzed cow's milk infant formula with a probiotic
- Primary Outcome Measures
Name Time Method Infant Behavior Diary 21 Days
- Secondary Outcome Measures
Name Time Method Body Weight Baseline and Day 21 Recall of Tolerance Questionnaire Baseline and Day 21 Infant Behavior Questionnaire - Revised Baseline and Day 21 Recall of formula intake at each visit Baseline, Day 10, and Day 18 Fecal microbiome and Fecal calprotectin Baseline and Day 21 Medically-confirmed Adverse Events 21 Days
Trial Locations
- Locations (1)
Children's Nutrition Research Center
🇺🇸Houston, Texas, United States