Randomized Study of Tauroursodeoxycholic Acid in Prophylactic Therapy of Total Parenteral Nutrition Associated Cholestasis in Infants
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/16/2015 |
| Start Date: | June 1998 |
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.
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.
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.
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.
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
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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