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

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ClinicalTrials.gov Identifier: NCT01974336
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Kong Wencheng, 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.

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: ursodeoxycholic acid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol
U.S. FDA Resources

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



Primary Outcome Measures :
  1. The biochemical indicator of patients' liver function during oral UDCA or placebo [ Time Frame: 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 :
  1. the changs of composition of serum bile acid after oral UDCA or placebo [ Time Frame: 2 months ]
    we test the composition of serum bile acid at the beginning,2 months,4 months(the end) of the trial

  2. The changs of the level of fibroblast growth factor 19(FGF19) in the serum [ Time Frame: 4 months ]
    we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974336


Locations
China, Jiangsu
Jinling Hospital
Nanjing, Jiangsu, China, 200002
Sponsors and Collaborators
Jinling Hospital, China
National Natural Science Foundation of China
Investigators
Principal Investigator: Wencheng Kong, MD Nanjing University

Responsible Party: Kong Wencheng, Senior Resident, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01974336     History of Changes
Other Study ID Numbers: UDCA-PNAC-SBS
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Ursodeoxycholic Acid
Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Cholagogues and Choleretics
Gastrointestinal Agents