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

Study Overview
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Brief Summary
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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.

Official Title
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The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Intervention / Treatment
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* Drug: ursodeoxycholic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UDCA+placebo group<br>15-30mg/kg/d UDCA for 2 months + placebo for 2 months | Drug: ursodeoxycholic acid<br> <br> |
| Experimental: placebo+UDCA<br>placebo for 2 months+15-30mg/kg/d UDCA for 2 months | Drug: ursodeoxycholic acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 4 months |