Infants With Protein Sensitive Colitis

March 15, 2013 updated by: Abbott Nutrition

Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Infant Formula
Experimental formula to be fed ad libitum.
Other: Experimental Infant Formula
Nutritionally complete free amino acid-based medical food.
Other Names:
  • EleCare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Rated Symptom Score
Time Frame: 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.
Study Day (SD) 1 and 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Rank Stool Consistency
Time Frame: Study Day (SD) 2-4 and 40-42
Parent reported stool records
Study Day (SD) 2-4 and 40-42
Weight
Time Frame: Study Day (SD) 1 and 43 Visits
Weight gain during the feeding period
Study Day (SD) 1 and 43 Visits
Formula Intake
Time Frame: Study Day (SD) 2-4 and 40-42
Parent reported records of formula intake
Study Day (SD) 2-4 and 40-42
Daily Stool Number
Time Frame: Study Day (SD) 2-4 and 40-42
Parent reported stool records
Study Day (SD) 2-4 and 40-42
Stool Occult Blood
Time Frame: Study Day (SD) 2-4 and 40-42
Parent collected sample of infant stool
Study Day (SD) 2-4 and 40-42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene Borschel, PhD, RD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

February 1, 2001

Study Completion (Actual)

February 1, 2001

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 15, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AH75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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