Protein Sensitive Colitis
Conditions
Brief summary
Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.
Interventions
Nutritionally complete free amino acid-based medical food.
Sponsors
Abbott Nutrition
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Rated Symptom Score | Study Day (SD) 1 and 43 | Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Rank Stool Consistency | Study Day (SD) 2-4 and 40-42 | Parent reported stool records |
| Weight | Study Day (SD) 1 and 43 Visits | Weight gain during the feeding period |
| Formula Intake | Study Day (SD) 2-4 and 40-42 | Parent reported records of formula intake |
| Daily Stool Number | Study Day (SD) 2-4 and 40-42 | Parent reported stool records |
| Stool Occult Blood | Study Day (SD) 2-4 and 40-42 | Parent collected sample of infant stool |
Countries
United States
Outcome results
None listed