Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000503628
Ethics application status
Approved
Date submitted
8/05/2014
Date registered
12/05/2014
Date last updated
24/01/2019
Date data sharing statement initially provided
24/01/2019
Date results information initially provided
24/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Differences in gut bacteria of patients with Clostridium difficile infection and patients with ulcerative colitis before and after faecal microbiota transplantation
Scientific title
Single centre, proof-of-concept, exploratory, parallel, controlled study using high-throughput DNA sequencing techniques to compare differences in the gastrointestinal (GI) microflora of Clostridium difficile infection (CDI) and ulcerative colitis (UC) patients before and after faecal microbiota transplantation (FMT)
Secondary ID [1] 284565 0
Nil
Universal Trial Number (UTN)
U1111-1156-5909
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium difficile infection 291836 0
Ulcerative colitis 291837 0
Condition category
Condition code
Oral and Gastrointestinal 292201 292201 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 292202 292202 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 292220 292220 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Faecal microbiota transplantation (FMT). 2x 150mL FMTs will be administered on consecutive days. The first FMT will be administered via a colonosocope and the second FMT will be administered via a rectal enema.
Intervention code [1] 289337 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292071 0
Donor microbiota implantation (defined as 50% similarity to the donor) as measured by high-throughput DNA sequencing of bacteria in stool
Timepoint [1] 292071 0
Day 3, Day 7, Day 14 and Day 28 after FMT
Secondary outcome [1] 308149 0
Relationship between donor microbiota implantation and clinical improvement as defined by a 3 point or greater improvement in Mayo score for ulcerative colitis patients or eradication of Clostridium difficile infection (CDI) and improvement in bowel frequency to 1-2 stools per day in CDI patients.
Timepoint [1] 308149 0
Day 30 after FMT

Eligibility
Key inclusion criteria
6 months or greater history of active moderate ulcerative colitis (Mayo score of 4-10) or diarrhoea (greater than 3 motions per day) in association with a confirmed diagnosis of Clostridium difficile infection (toxin positive).
Never had FMT treatment for any reason.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females who are pregnant or lactating.
Unwilling to practice an effective method of contraception throughout the study period.
Unwilling to use a sodium picosulfate-based bowel preparation.
Severe anemia, leucopenia or granulocytopenia.
Detection of a gastrointestinal pathogen on stool analysis, with the exception of Clostridium difficile for the Clostridium difficile infection group only.
Participants with Crohn’s disease, indeterminate colitis or isolated proctitis <5 cm.
Constipation-predominant ulcerative colitis with <2 bowel motions/day.
Evidence or history of toxic megacolon.
Any other significant gastrointestinal conditions e.g. neoplasms, irritable bowel syndrome.
Participants who have had a colectomy, bowel resection or other major gastrointestinal surgery.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/04/2014
Actual
24/04/2014
Date of last participant enrolment
Anticipated
Actual
17/08/2015
Date of last data collection
Anticipated
Actual
17/08/2018
Sample size
Target
10
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2441 0
Centre for Digestive Diseases - Five Dock
Recruitment postcode(s) [1] 8061 0
2046 - Five Dock

Funding & Sponsors
Funding source category [1] 289195 0
Commercial sector/Industry
Name [1] 289195 0
Centre for Digestive Diseases
Country [1] 289195 0
Australia
Funding source category [2] 289196 0
Government body
Name [2] 289196 0
European Molecular Biology Laboratory
Country [2] 289196 0
Germany
Primary sponsor type
Commercial sector/Industry
Name
Centre for Digestive Diseases
Address
Level 1, 229 Great North Rd
Five Dock NSW 2046
Country
Australia
Secondary sponsor category [1] 287865 0
None
Name [1] 287865 0
Address [1] 287865 0
Country [1] 287865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290970 0
Centre for Digestive Diseases Human Research Ethics Committee
Ethics committee address [1] 290970 0
Level 1, 229 Great North Rd
Five Dock NSW 2046
Ethics committee country [1] 290970 0
Australia
Date submitted for ethics approval [1] 290970 0
28/01/2014
Approval date [1] 290970 0
20/03/2014
Ethics approval number [1] 290970 0
CDD14/C02

Summary
Brief summary
Faecal microbiota transplantation (FMT) is a highly successful treatment for Clostridium difficile infection (CDI) with success rates of over 90%. Success rates of FMT treatment for ulcerative colitis (UC) are lower.

The success of FMT in CDI treatment is believed to be in part due to the implantation of the full complement of bacteria from the FMT into the patient's bowel. It is unclear if this implantation occurs with FMT in UC patients. The lower success rate of FMT treatment for UC may be due to a failure of the bacteria from the FMT to implant in the bowel's of UC patients.

This study will compare the composition and changes in the gut bacteria before and after FMT in patients with CDI and in patients with UC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48202 0
Prof Thomas Borody
Address 48202 0
Centre for Digestive Diseases
Level 1, 229 Great North Rd
Five Dock NSW 2046
Country 48202 0
Australia
Phone 48202 0
+61 2 9713 4011
Fax 48202 0
Email 48202 0
[email protected]
Contact person for public queries
Name 48203 0
Ms Enmoore Lin
Address 48203 0
Centre for Digestive Diseases
Level 1, 229 Great North Rd
Five Dock NSW 2046
Country 48203 0
Australia
Phone 48203 0
+61 2 9713 4011
Fax 48203 0
Email 48203 0
[email protected]
Contact person for scientific queries
Name 48204 0
Ms Enmoore Lin
Address 48204 0
Centre for Digestive Diseases
Level 1, 229 Great North Rd
Five Dock NSW 2046
Country 48204 0
Australia
Phone 48204 0
+61 2 9713 4011
Fax 48204 0
Email 48204 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.