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

Phase 4

Completed

• Conditions: Short Bowel Syndrome
• Interventions: Drug: ursodeoxycholic acid

• Registration Number: NCT01974336
• Lead Sponsor: Jinling Hospital, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-10-20
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-11-01
• Primary Completion: 2016-04
• Study Completion: 2016-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo+UDCA	ursodeoxycholic acid	placebo for 2 months+15-30mg/kg/d UDCA for 2 months
UDCA+placebo group	ursodeoxycholic acid	15-30mg/kg/d UDCA for 2 months + placebo for 2 months

Primary Outcome Measures

Name	Time	Method
The biochemical indicator of patients' liver function during oral UDCA or placebo	2 months	detect the biochemical indicator of patients' liver function(Serum bilirubin, GGT Valley, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase) during oral UDCA or placebo

Secondary Outcome Measures

Name	Time	Method
the changs of composition of serum bile acid after oral UDCA or placebo	2 months	we test the composition of serum bile acid at the beginning,2 months,4 months(the end) of the trial
The changs of the level of fibroblast growth factor 19(FGF19) in the serum	4 months	we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China