The efficacy and safety of faecal microbiota transplantation for recurrent or relapsing Clostridium difficile in Western Australia

Not Applicable

Recruiting

• Conditions: Recurrent or relapsing Clostridium difficile infection; Infection - Other infectious diseases

• Registration Number: ACTRN12615001220550
• Lead Sponsor: Fiona Stanley Fremantle Hospital Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients aged >18 yr old within the Western Australian Health system
Symptoms of diarrhoea (Bristol Stool Scale > 5) with 1 > bowel movements per day above their usual bowel frequency
Stool examination is positive for Clostridium difficile toxin PCR
Have completed at least two courses of standard antibiotic therapy for Clostridium difficile infection within 6 months of recruitment

Exclusion Criteria

No diarrhoea or gastrointestinal symptoms
Negative stool Clostridium difficile toxin PCR
Not completed 2 standard courses of antibiotic therapy for clostridium difficile infection within 6 months of recruitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients cured of clostridium difficile infection as defined by resolution of symptoms, reduction in inflammatory markers and negative microbiology stool analysis.[Assement will occur at 2, 12, 26,and 52 weeks post FMT]

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment as documented at by EQ-5D-5L questionnaire[2, 12, 26 and 52 weeks post FMT]