Infants With Protein Sensitive Colitis

Abbott

Status: Completed

Conditions: Protein Sensitive Colitis

Treatments: Other: Experimental Infant Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813526

AH75

Details and patient eligibility

About

Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.

Enrollment: 53 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Less than or equal to 6 months of age
• 36-42 weeks gestational age at birth
• Singleton or Twin birth
• Diagnosed with protein sensitive colitis
• Negative stool culture at time of study entry
• No previous history of consuming free amino acid-based medical food
• Not receiving cisapride or steroids
• No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
• No milk or soy products for the duration of the study

Trial design

53 participants in 1 patient group

Experimental Infant Formula

Experimental group

Description:

Experimental formula to be fed ad libitum.

Treatment:

Other: Experimental Infant Formula