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Completed

NCT Number: NCT01812629

Nutritional Management of Children With Chronic Diarrhea

The study objective is to assess the growth, tolerance and efficacy of a complete amino acid-based medical food in children with chronic diarrhea.

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Key information

Conditions

Growth and Tolerance Infant Study

Age range

Up to 9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National Medical Center, Washington D.C., District of Columbia, 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 9 months of age at enrollment
  • Candidates for an elemental formula
  • 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 underlying GI disease with chronic diarrhea controlled by a semi-elemental or elemental formula
  • 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. Physician determined target outcome

    Time frame: Study Day (SD)1-84

    Outcome dependent on individual subject assessment and may include decreased stool number, decreased vomiting, decreased gas, weight gain, increased caloric intake, increased protein intake, increased serum albumin concentration, increased hemoglobin concentration, better acceptance of supplemental formula.

Secondary 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. Gastro-Intestinal Tolerance

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

    Parent reported record of incidence of regurgitation.

  3. Stool characteristics

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

    Parent completed diary of stool consistency, frequency/volume.

  4. Blood Chemistry

    Time frame: Study Day (SD) 1 and 84

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

  5. Anthropometrics

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

    Weight and length

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Clinical Management of Children With Chronic Diarrhea

Important dates

Study start
1997
Primary completion
1999
Study completion
1999
First posted
Mar 18, 2013
Registry last updated
Mar 18, 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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