Ursodeoxycholic Acid in C. Difficile Infection

NHS Trust

Status: Terminated

Conditions: Clostridioides Difficile Infection

Treatments: Drug: Ursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05526807

17GA025

Details and patient eligibility

About

The primary objective of the study is to assess tolerability and adherence to treatment with ursodeoxycholic acid

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of a course of antibiotic treatment for C. difficile infection within the previous 7 days

Exclusion criteria

• • Pregnant or Breast-feeding

  • Gall bladder inflammation
  • Frequent episodes of biliary colic
  • Occlusion of the common bile duct or cystic duct
  • Active small intestinal inflammation
  • Previous resection of distal small intestine
  • Treatment with bile salt binding agents, ciclosporin or ciprofloxacin
  • Diarrhoea (from any cause) at study initiation
  • hypersensitivity to bile acids or any excipient of the formulation
  • Life expectancy less than 6 months

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Ursodeoxycholic acid

Experimental group

Description:

Only one arm - subjects receiving ursodeoxycholic acid

Treatment:

Drug: Ursodeoxycholic acid