Stool
Conditions
Brief summary
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.
Interventions
OTHERControl
Routine cow's milk-based infant formula
OTHERInvestigational
Partially-hydrolyzed cow's milk protein infant formula
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
28 Days to 300 Days
Healthy volunteers
Yes
Inclusion criteria
* Singleton 28-300 days of age at randomization * Gestational age less than or equal to 35 weeks * Receiving minimum 18oz infant formula in the 24hrs prior to randomization * History of hard stools or stooling difficulty * Signed informed consent and protected health information
Exclusion criteria
* Current diagnosis of cow's milk protein allergy or intolerance * Use of extensively hydrolyzed or amino acid formula at randomization * Any abdominal or gastrointestinal surgery prior to randomization * History of underlying metabolic or chronic disease or congenital malformation * Organic causes of constipation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool consistency measured by MJN stool consistency scale | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Stool frequency | 14 days |
| Formula acceptance measured by intake diary | 14 days |
| Formula gastrointestinal tolerance measured by diary | 14 days |
| Bowel movement characteristics by diary | 14 days |
| Medically confirmed adverse events throughout the study period | 14 days |
Countries
United States
Outcome results
None listed