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

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

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 Overview

• Status: Completed
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: ursodeoxycholic acid

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 200002
      • Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jinling Hospital, China
• Collaborators: National Natural Science Foundation of China
• Investigators: Principal Investigator: Wencheng Kong, MD, Nanjing University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 20, 2013
• First Submitted That Met QC Criteria: October 26, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome; Gastrointestinal Agents; Cholagogues and Choleretics; Ursodeoxycholic Acid
• Other Study ID Numbers: UDCA-PNAC-SBS