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NCT Number: NCT01974336

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

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jinling Hospital

Nanjing, Jiangsu, 200002, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ursodeoxycholic acid

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jinling Hospital, China

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 1, 2013
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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