Common Infant Feeding Problems
Conditions
Brief summary
This clinical trial will determine if the formula given to infants experiencing fussiness, crying, cramping, gas, and/or diarrhea, is accepted and well tolerated and helps to resolve symptoms.
Interventions
OTHERMarketed milk-based lactose-containing infant formula
OTHERMarketed milk-based lactose-free infant formula
OTHERMarketed soy-based lactose-free infant formula
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* Subject is between 2 and 12 weeks of age * Subject has currently been receiving a milk-based lactose-containing formula for at least 5 days as the sole item of diet * Subject has never switched to any lactose free formula * The parent/guardian who will fill out the quality of life questionnaire is female and at least 18 years of age * The parent/guardian has reported an unsolicited history of feeding problems including fussiness/crying/cramping, gas, or diarrhea * Signed Informed Consent
Exclusion criteria
* Subject is in daycare for more than 4 hours per day (20 hours per week) * Subject has serious perinatal complications, underlying disease or congenital malformations that impair normal formula feeding * The parent/guardian who will fill out the quality of life questionnaire has chronic illness, e.g. diabetes, inflammatory bowel disease or other illness requiring daily medication or treatment * Subject has acute infectious diarrhea or any other intercurrent illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Infant Temperament Questionnaire | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Infant Characteristic Questionnaire | 14 days |
| Maternal Efficacy Questionnaire | 14 days |
| Mental Health Inventory Questionnaire | 14 days |
Countries
Canada, United States
Outcome results
None listed