Infants With Protein Sensitive Colitis

Protein Sensitive Colitis Clinical Trial

Official title:

Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813526
• Other study ID #: AH75
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: March 15, 2013
• Start date: November 1999
• Est. completion date: February 2001

Study information

• Verified date: March 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Colitis
• Protein Sensitive Colitis

Intervention

Other:
• Experimental Infant Formula
Nutritionally complete free amino acid-based medical food.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Children's Hospital	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Study Day (SD) 1 and 43	No
Secondary	Mean Rank Stool Consistency	Parent reported stool records	Study Day (SD) 2-4 and 40-42	No
Secondary	Weight	Weight gain during the feeding period	Study Day (SD) 1 and 43 Visits	No
Secondary	Formula Intake	Parent reported records of formula intake	Study Day (SD) 2-4 and 40-42	No
Secondary	Daily Stool Number	Parent reported stool records	Study Day (SD) 2-4 and 40-42	No
Secondary	Stool Occult Blood	Parent collected sample of infant stool	Study Day (SD) 2-4 and 40-42	No