Tolerance
Conditions
Brief summary
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
Interventions
OTHERControl
Marketed partially hydrolyzed cow's milk protein infant formula
OTHERInvestigational
Partially hydrolyzed cow's milk protein infant formula with a probiotic
Sponsors
Baylor College of Medicine
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant Behavior Diary | 21 Days |
Secondary
| Measure | Time frame |
|---|---|
| Body Weight | Baseline and Day 21 |
| Infant Behavior Questionnaire - Revised | Baseline and Day 21 |
| Recall of Tolerance Questionnaire | Baseline and Day 21 |
| Fecal microbiome and Fecal calprotectin | Baseline and Day 21 |
| Medically-confirmed Adverse Events | 21 Days |
| Recall of formula intake at each visit | Baseline, Day 10, and Day 18 |
Countries
United States
Outcome results
None listed