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Completed

NCT Number: NCT00004410

Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants

OBJECTIVES: I. Determine whether infants treated with tauroursodeoxycholic acid (TUDCA) have a lower peak direct bilirubin, ALT, AST, glutamyltranspeptidase levels and a reduced duration of cholestasis compared to the nontreatment arm.

II. Determine the significance of lower birth weight and longer duration of total parenteral nutrition (TPN) on increasing risk of TPN associated cholestasis and increasing benefit from TUDCA therapy.

III. Determine whether TUDCA therapy leads to significant reduction in the appearance of biliary tract sludge and/or stone formation in these infants.

IV. Determine whether TUDCA therapy leads to reduced urinary excretion of potentially hepatotoxic bile acids as compared to the untreated arm matched for birth weight and duration of TPN.

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Key information

Conditions

Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Disease Attributes Gastrointestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Age range

Up to 20 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospitals and Clinics - Minneapolis, Minneapolis, Minnesota, United States

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About this study

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by birth weight.

Patients are randomized in pairs by birth weight to receive either a placebo in arm I or tauroursodeoxycholic acid (TUDCA) in arm II. TUDCA is administered by mouth, nasogastric tube, or gastrostomy tube twice daily. After 2 weeks of therapy, a bile sample is obtained via a duodenal tube. An ultrasound examination of the liver and biliary tract is performed after 2 weeks and every 3 weeks thereafter until discontinuation of therapy or until presence of biliary tract sludge is noted on 2 consecutive examinations.

Completion date provided represents the completion date of the grant per OOPD records

Who can participate

Healthy volunteers accepted: No

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

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Hospitalized infants who are anticipated to require total parenteral nutrition for greater than 2 weeks and have: Major gastrointestinal anomalies (gastroschisis, ruptured omphalocele) OR Resection (necrotizing enterocolitis, volvulus)
  • No evidence of biliary tract abnormalities
  • No evidence of other forms of cholestatic liver disease

--Patient Characteristics--

  • Renal: No life threatening renal disease
  • Cardiovascular: No life threatening cardiovascular disease
  • Other: No multiple congenital abnormalities

Treatment and study plan

tauroursodeoxycholic acid

Drug

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Important dates

Study start
1998
Study completion
2002
First posted
Oct 19, 1999
Registry last updated
Mar 25, 2015

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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