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

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974336
• Other study ID #: UDCA-PNAC-SBS
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2013
• Last updated: February 23, 2017
• Start date: January 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• ursodeoxycholic acid

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jinling Hospital, China	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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