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Trial registered on ANZCTR


Registration number
ACTRN12615001220550
Ethics application status
Approved
Date submitted
4/11/2015
Date registered
9/11/2015
Date last updated
29/10/2018
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy and safety of faecal microbiota transplantation for recurrent or relapsing Clostridium difficile in Western Australia
Scientific title
Faecal Microbiota Transplantation (FMT) in recurrent or relapsing Clostridium difficile (CDI) in Western Australia, assessment of efficacy and safety
Secondary ID [1] 287796 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent or relapsing Clostridium difficile infection 296678 0
Condition category
Condition code
Infection 296907 296907 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Affected patients will be screen for CDI by stool toxin PCR and if positive will be offered FMT. They can opt for a related donor or use a frozed sample from an unrelated donor. Donors (related or unrelated) will be screen by a gastroenterologist and an infectious disease consultant. They must be aged 18 to 65 years old, not had any antibiotics for 6 months, viral gastroenteritis for 3 months, travel outside of Australia within the last month, or any past history of gastrointestinal diseases including irritible bowel syndrome and colonic polyps, or if there is a significant family history of bowel cancer then they must have had a colonoscopy within 3 years. There must be no evidence of active infection with hepatitis viruses and other selected blood borne virus plus no history of significant autoimmune disease or severe environmental allergy. Their stool will be screen for CDI as well as a braod spectrum of bacterial, viral or parasitic infections. Unrelated donors will be excluded if there is evidence, physical or biochemical, of metabolic syndrome, cardiovascular disease, depression or serological evidence of HTLV1 or 2.

Donors will provide a whole fresh stool in a clean container. the stool will be homogenised by a gastroenterologist in a fumigated cabinet. Each stool sample will be divided into 80-100g alliquots, suspended in normal saline, filtered to remove particulate matter and made up to a volume of 250ml with more normal saline. For fresh related donors the sample is then taken to the endoscopy room where it is delivered into the right colon of the recipient via a colonoscope after the recipient has undergone standard bowel preparation for colonoscopy.

For Frozen sample the the filtered faecal microbiota suspension will be centrifuged a 5,000g for 15 minutes and then re-suspended in half the volume of normal saline with 10% sterile pharmaceutical grade glycerol added to aid bacterial survival during freezing. Samples are then stored for upto 104 weeks at -80 degrees C. Thawing of samples occurs over 2 hours in an ice bath prior to FMT as described above.

A register of samples will be kept for the purpose of clinical governance and a single sample from each unrelated donnor will be kept for the duration of the study incase of need for retesting.

Patients who have contraindications for colonoscopy can be given the FMT via a nasogastric tube. The route of FMT administration will be recorded for each patient.

The FMT will be a once only treatment. However if patients fail to respond as judged by clinical improvement and positive stool CDI toxin PCR, a second FMT can be offered after 1 week.. If the patient fails to respond to a second FMT, no further FMT will be offered.
Intervention code [1] 293190 0
Treatment: Other
Comparator / control treatment
No control group or similar
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296516 0
Proportion of patients cured of clostridium difficile infection as defined by resolution of symptoms, reduction in inflammatory markers and negative microbiology stool analysis.
Timepoint [1] 296516 0
Assement will occur at 2, 12, 26,and 52 weeks post FMT
Secondary outcome [1] 318643 0
Quality of life assessment as documented at by EQ-5D-5L questionnaire
Timepoint [1] 318643 0
2, 12, 26 and 52 weeks post FMT

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/12/2015
Actual
17/02/2016
Date of last participant enrolment
Anticipated
2/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4562 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 4563 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 292324 0
Hospital
Name [1] 292324 0
Fiona Stanley Fremantle Hospital Group
Country [1] 292324 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Fremantle Hospital Group
Address
Barry Marshall Parade, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 300645 0
None
Name [1] 300645 0
None
Address [1] 300645 0
Country [1] 300645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293792 0
South Metropolitan Health Service Human Research and Ethics Committee
Ethics committee address [1] 293792 0
Ethics committee country [1] 293792 0
Australia
Date submitted for ethics approval [1] 293792 0
09/12/2014
Approval date [1] 293792 0
09/12/2014
Ethics approval number [1] 293792 0
14/60

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61342 0
Dr Oliver Waters
Address 61342 0
Gastroenterology Department CD09, Fiona Stanley Hospital, Barry Marshall Parade, Murdoch WA 6050
Country 61342 0
Australia
Phone 61342 0
+61861522222
Fax 61342 0
Email 61342 0
oliver.waters2@health.wa.gov.au
Contact person for public queries
Name 61343 0
Oliver Waters
Address 61343 0
Gastroenterology Department CD09, Fiona Stanley Hospital, Barry Marshall Parade, Murdoch WA 6050
Country 61343 0
Australia
Phone 61343 0
+61861522222
Fax 61343 0
Email 61343 0
oliver.waters2@health.wa.gov.au
Contact person for scientific queries
Name 61344 0
Oliver Waters
Address 61344 0
Gastroenterology Department CD09, Fiona Stanley Hospital, Barry Marshall Parade, Murdoch WA 6050
Country 61344 0
Australia
Phone 61344 0
+61861522222
Fax 61344 0
Email 61344 0
oliver.waters2@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
We have yet to discuss this amongst the investigators yet.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.