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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01974336

Enrollment

Registered

2013-11-01

Start date

2013-01-31

Completion date

2016-09-30

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Short Bowel Syndrome

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.

Interventions

DRUGursodeoxycholic acid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
The biochemical indicator of patients' liver function during oral UDCA or placebo	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

Measure	Time frame	Description
the changs of composition of serum bile acid after oral UDCA or placebo	2 months	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	4 months	we test the level of FGF19 in the serum at the beginning,2 months,4months(the end) of the trail.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026