The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients

Phase 4CompletedNCT01974336

Jinling Hospital, China30 enrolled

Overview

The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Short Bowel Syndrome

Interventions

ursodeoxycholic acidDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with short bowel syndrome supported by total parenteral nutrition. * Patients have intestine more than 50cm. * Requirements of informed consent and assent of participant, parent or legal guardian as applicable * Consciousness and ability to cooperate. Exclusion Criteria: * Patients have obstruction of biliary tract, infection, autoimmune disease, cancer * Patients have intestine less than 50cm * A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease * Female with positive pregnancy * Allergy to ursodeoxycholic acid

Locations (1)

Jinling Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

The biochemical indicator of patients' liver function during oral UDCA or placebo

detect the biochemical indicator of patients' liver function(Serum bilirubin, GGT Valley, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase) during oral UDCA or placebo

Time frame: 2 months

Secondary Outcomes

the changs of composition of serum bile acid after oral UDCA or placebo

we test the composition of serum bile acid at the beginning,2 months,4 months(the end) of the trial

Time frame: 2 months

The changs of the level of fibroblast growth factor 19(FGF19) in the serum

we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.

Time frame: 4 months

Data from ClinicalTrials.gov

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