CClinicalTrials.gg
CompletedNCT01974336Updated Feb 24, 2017

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

A Phase 4 interventional study of ursodeoxycholic acid in Short Bowel Syndrome, sponsored by Jinling Hospital, China. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-24.

Sponsored by Jinling Hospital, China · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2013, registered Oct 2013).
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Short Bowel Syndrome
03

In context

Short Bowel Syndrome

149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.

This study's enrollment of 30 is above the median of 20 across 100 interventional studies indexed under Short Bowel Syndrome.

Browse Short Bowel Syndrome studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • Drugursodeoxycholic acid
06

What researchers measure

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

    Time frame: 2 months

Secondary outcomes

  1. 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

    Time frame: 2 months

  2. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Jinling Hospital
    Nanjing, Jiangsu 200002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01974336
Lead sponsor
Jinling Hospital, China
Collaborators
National Natural Science Foundation of China
Responsible party
Kong Wencheng (Senior Resident, Jinling Hospital, China) — Principal investigator
First posted
Nov 1, 2013
Start date
Jan 2013
Primary completion
Apr 2016
Completion
Sep 2016
Last update
Feb 24, 2017

Study contacts

Wencheng Kong, MD
principal investigator · Nanjing University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion