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Trial registered on ANZCTR


Registration number
ACTRN12622000797774
Ethics application status
Approved
Date submitted
10/05/2022
Date registered
7/06/2022
Date last updated
7/06/2022
Date data sharing statement initially provided
7/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Faecal Microbial Transplantation for Graft-Versus-Host Disease
Scientific title
Feasibility and Safety of Faecal Microbial Transplantation for Graft-Versus-Host Disease
Secondary ID [1] 307106 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Micro GVHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Graft-versus-Host Disease 326266 0
Bone Marrow Transplantation 326267 0
Condition category
Condition code
Blood 323569 323569 0 0
Haematological diseases
Inflammatory and Immune System 323570 323570 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Faecal Microbiota Transplant. A single dose of donor faecal material provided by The Australian Red Cross Lifeblood Microbiome project, will be administered via naso-duodenal tube to patients at the Royal Brisbane and Women's Hospital. Recipients will be patients who have had an allogeneic bone marrow transplant and who have steroid dependent (SD) or steroid refractory (SR) Graft-versus-Host Disease. The Faecal Microbiota for Transplant is a 150g suspension in normal saline derived from 50g of human donor stool. Admission will be directly supervised by nursing staff in the RBWH Bone Marrow Transplant Unit.
Intervention code [1] 323557 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331325 0
Safety. Adverse events will be graded according to CTCAE5.
Timepoint [1] 331325 0
6 months post delivery of faecal microbial transplant.
Secondary outcome [1] 409534 0
Feasibility of delivery of the Australian Red Cross Lifeblood Faecal Microbiota for Transplant products to patients at the Royal Brisbane and Women's Hospital, measured through number of patients successfully delivered a FMT product. Data will be collected from the clinical trial case report form and from patient records.
Timepoint [1] 409534 0
6 months post delivery of faecal microbial transplant.
Secondary outcome [2] 409535 0
Efficacy with respect to GVHD response will be assessed using European Society for Blood and Marrow Transplantation-National Institutes of Health- Centre for International Blood and Marrow Transplant Research (EBMT-NIH-CIBMTR) Task Force Criteria.
Timepoint [2] 409535 0
6 months post delivery of faecal microbial transplant.

Eligibility
Key inclusion criteria
1. Recipient of allogeneic bone marrow transplantation
2. Clinical and Histological diagnosis of gastrointestinal Graft-versus-Host Disease from any site in the GI tract.
3. Steroid refractory (SR) and / or steroid dependent (SD) GVHD defined as;
- Progression after 3 days of 2mg/kg of Prednisone or equivalent.
- No change after 7 days of 2mg/kg of Prednisone or equivalent.
- Incomplete response (<50% reduction in stool volume) after 14 days of 2mg/kg of
Prednisone or equivalent.
- Recurrence on steroid taper when receiving >50mg of prednisolone per day.
4. Ability to provide voluntary informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindication or inability to insert a naso-duodenal tube; including cytopenias which prevent safe insertion of naso-duodenal tube despite transfusional support.
2. Active uncontrolled bacterial, fungal or viral infections
3. Pregnancy or breast feeding

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pilot Study
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22342 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 37503 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 311413 0
Charities/Societies/Foundations
Name [1] 311413 0
RBWH Foundation
Country [1] 311413 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 312803 0
None
Name [1] 312803 0
Address [1] 312803 0
Country [1] 312803 0
Other collaborator category [1] 282293 0
Other
Name [1] 282293 0
QIMR Berghofer Medical Research Institute
Address [1] 282293 0
300 Herston Road
HERSTON QLD 4003
Country [1] 282293 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310892 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 310892 0
Butterfield Street
HERSTON QLD 4029
Ethics committee country [1] 310892 0
Australia
Date submitted for ethics approval [1] 310892 0
05/11/2021
Approval date [1] 310892 0
03/12/2021
Ethics approval number [1] 310892 0
HREC/2021/QRBW/79181

Summary
Brief summary
This study will determine safety and feasibility of therapeutic FMT for steroidrefractory (SR) and steroid dependent (SD) acute gastrointestinal (GI) Graftversus-Host Disease (GVHD) ocurring in patients after allogeneic bone marrow transplantation at Royal Brisbane and Women’s Hospital. It is a phase I/II open label, pilot study and will treat 10 participants. FMT is an effective therapy to restore the healthy GI microbial flora in recurrent Clostridiodes difficile (rCDI) gastroenteritis. There is emerging evidence of efficacy for FMT in GI-GVHD, an immune-mediated complication of bone marrow transplantation. FMT offers a novel and cost effective therapeutic option to reduce GVHD mortality and the morbidity associated with other secondary therapies, i.e. broad spectrum immunosuppressive treatments including Antithymocyte globulin (ATGAM). FMT will be offered in combination with standard of care including Ruxolitinib and following first line treatment with steroids.
Efficacy of FMT as a therapy for SR and SD GI-GVHD will be assessed as a secondary endpoint. Laboratory samples for correlative scientific analysis will be collected to explore the mechanistic basis for therapeutic efficacy of FMT.

The FMT product will be supplied by Australian Red Cross Lifeblood Microbiome, who are a TGA licenced manufacturer of voluntary donated human stool derived faecal Microbiota for transplant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119254 0
Dr Andrea Henden
Address 119254 0
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 119254 0
Australia
Phone 119254 0
+61 7 36461340
Fax 119254 0
Email 119254 0
andrea.henden@health.qld.gov.au
Contact person for public queries
Name 119255 0
Dr Andrea Henden
Address 119255 0
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 119255 0
Australia
Phone 119255 0
+61 7 36468111
Fax 119255 0
Email 119255 0
andrea.henden@health.qld.gov.au
Contact person for scientific queries
Name 119256 0
Dr Andrea Henden
Address 119256 0
Royal Brisbane and Women's Hospital
Butterfield Street
HERSTON QLD 4029
Country 119256 0
Australia
Phone 119256 0
+61 7 36468111
Fax 119256 0
Email 119256 0
andrea.henden@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Pilot trial. Participant data will be kept confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15998Study protocol  andrea.henden@health.qld.gov.au On request from the corresponding Investigator



Results publications and other study-related documents

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

Documents added automatically
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