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

Primary Purpose

Short Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ursodeoxycholic acid
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Short Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

UDCA+placebo group

placebo+UDCA

Arm Description

15-30mg/kg/d UDCA for 2 months + placebo for 2 months

placebo for 2 months+15-30mg/kg/d UDCA for 2 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.

Full Information

First Posted
October 20, 2013
Last Updated
February 23, 2017
Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT01974336
Brief Title
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Short Bowel Syndrome Patients
Official Title
The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UDCA+placebo group
Arm Type
Experimental
Arm Description
15-30mg/kg/d UDCA for 2 months + placebo for 2 months
Arm Title
placebo+UDCA
Arm Type
Experimental
Arm Description
placebo for 2 months+15-30mg/kg/d UDCA for 2 months
Intervention Type
Drug
Intervention Name(s)
ursodeoxycholic acid
Primary Outcome Measure Information:
Title
The biochemical indicator of patients' liver function during oral UDCA or placebo
Description
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 Outcome Measure Information:
Title
the changs of composition of serum bile acid after oral UDCA or placebo
Description
we test the composition of serum bile acid at the beginning,2 months,4 months(the end) of the trial
Time Frame
2 months
Title
The changs of the level of fibroblast growth factor 19(FGF19) in the serum
Description
we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wencheng Kong, MD
Organizational Affiliation
Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
200002
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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