Infants With Protein Sensitive Colitis

Abbott Nutrition53 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

SINGLE

Enrollment

Conditions

Protein Sensitive Colitis

Interventions

Experimental Infant FormulaOTHER

Nutritionally complete free amino acid-based medical food.

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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

Locations (2)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Children's Hospital

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Physician Rated Symptom Score

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.

Time frame: Study Day (SD) 1 and 43

Secondary Outcomes

Mean Rank Stool Consistency

Parent reported stool records

Time frame: Study Day (SD) 2-4 and 40-42

Weight

Weight gain during the feeding period

Time frame: Study Day (SD) 1 and 43 Visits

Formula Intake

Parent reported records of formula intake

Time frame: Study Day (SD) 2-4 and 40-42

Daily Stool Number

Parent reported stool records

Time frame: Study Day (SD) 2-4 and 40-42

Stool Occult Blood

Parent collected sample of infant stool

Time frame: Study Day (SD) 2-4 and 40-42

Data from ClinicalTrials.gov

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