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

NCT01974336 | Completed Phase 4 DMC

• 1 other identifier: UDCA-PNAC-SBS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the changs of composition of serum bile acid after oral UDCA or placebo

  2 months

• The changs of the level of fibroblast growth factor 19(FGF19) in the serum

  4 months

Study Arms (2)

UDCA+placebo group

EXPERIMENTAL

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

Drug: ursodeoxycholic acid

placebo+UDCA

EXPERIMENTAL

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

Drug: ursodeoxycholic acid

Interventions

ursodeoxycholic acid DRUG

UDCA+placebo group; placebo+UDCA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 200002, China

Location

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Wencheng Kong, MD

  Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: October 20, 2013
• First Posted: November 1, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

CN (1)