The Evaluation of Infant Formulas Fed to Infants With Common Feeding Problems

Mead Johnson Nutrition

Status

Completed

Conditions

Common Infant Feeding Problems

Treatments

Other: Marketed milk-based lactose-containing infant formula

Other: Marketed milk-based lactose-free infant formula

Other: Marketed soy-based lactose-free infant formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT01934257

3332-5

Details and patient eligibility

About

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.

Enrollment

296 patients

Sex

All

Ages

2 to 12 weeks old

Volunteers

No Healthy Volunteers

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