Status:
COMPLETED
Infants With Protein Sensitive Colitis
Lead Sponsor:
Abbott Nutrition
Conditions:
Protein Sensitive Colitis
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2001
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01813526
Start Date
November 1 1999
End Date
February 1 2001
Last Update
March 19 2013
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Children's Hospital
Omaha, Nebraska, United States, 68114