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OpenTrials
Completed

NCT Number: NCT01813526

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.

Completed

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Key information

Conditions

Protein Sensitive Colitis

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Infant Formula

Other

Nutritionally complete free amino acid-based medical food.

Other names: EleCare

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mean Rank Stool Consistency

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

    Parent reported stool records

  2. Weight

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

    Weight gain during the feeding period

  3. Formula Intake

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

    Parent reported records of formula intake

  4. Daily Stool Number

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

    Parent reported stool records

  5. Stool Occult Blood

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

    Parent collected sample of infant stool

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Evaluation of an Elemental Formula in Infants With Protein Sensitive Colitis

Important dates

Study start
1999
Primary completion
2001
Study completion
2001
First posted
Mar 19, 2013
Registry last updated
Mar 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.