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OpenTrials
Completed

NCT Number: NCT01820494

Nutritional Management of Infants With Chronic Diarrhea

The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.

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Key information

Conditions

Growth and Tolerance Infant Study

Age range

Up to 12 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 12 months of age at enrollment
  • Candidates for elemental feeding
  • Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
  • Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion criteria

  • Any non-approved concomitant study

Treatment and study plan

Experimental Infant Formula

Other

Infant formula to be fed ad libitum

Other names: EleCare

Primary outcomes

  1. Weight

    Time frame: Study Day (SD) 1, 28 and 84

    Change in weight from baseline.

Secondary outcomes

  1. Stool Characteristics

    Time frame: Study Day (SD) 2-4, 5-7, 25-27 and 81-83

    Parent completed diary of stool consistency, frequency/volume.

Other outcomes

  1. Dietary Assessment

    Time frame: Study day (SD) 2-4, 5-7, 25-27 and 81-83

    Parent completed record of infant dietary intake.

  2. Blood Chemistry

    Time frame: Study Day (SD) 1 and 84

    Hemoglobin, hematocrit, serum albumin, total protein, urea nitrogen, alkaline phosphatase

  3. Physician Assessment of Abdominal Complaints

    Time frame: Study Day (SD) 1, 28 and 84

    Individualized per subject, may include decreased vomiting, stool number or volume or increased weight gain.

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Mar 28, 2013
Registry last updated
Mar 28, 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.

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