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

J

Jinling Hospital, China

Status and phase

Completed
Phase 4

Conditions

Short Bowel Syndrome

Treatments

Drug: ursodeoxycholic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01974336
UDCA-PNAC-SBS

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

30 participants in 2 patient groups

UDCA+placebo group
Experimental group
Description:
15-30mg/kg/d UDCA for 2 months + placebo for 2 months
Treatment:
Drug: ursodeoxycholic acid
placebo+UDCA
Experimental group
Description:
placebo for 2 months+15-30mg/kg/d UDCA for 2 months
Treatment:
Drug: ursodeoxycholic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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