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Trial registered on ANZCTR


Registration number
ACTRN12624001104549
Ethics application status
Approved
Date submitted
26/08/2024
Date registered
13/09/2024
Date last updated
13/09/2024
Date data sharing statement initially provided
13/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness and safety of faecal transplantation in reducing the side effects of blood cancer treatment
Scientific title
Evaluating the clinical efficacy and safety of encapsulated Faecal Microbiota Transplantation (FMT) in reducing the side effects of Hematopoietic Stem Cell Transplantation (HSCT)
Secondary ID [1] 312816 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HSCT-BIOME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myeloma
 334898 0
lymphoma 334899 0
blood cancer 334900 0
Condition category
Condition code
Cancer 331444 331444 0 0
Myeloma
Cancer 331445 331445 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 331446 331446 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Encapsulated faecal microbiota transplantation (FMT) administered over two courses (each course = 36 capsules, containing 25g stool).
- FMT#1: 6 capsules a day for 6 days starting 1 week before conditioning
chemotherapy
- FMT#2: 6 capsules a day for 2 days then 2 capsules (ONCE DAILY) a day
until course is complete (total 14 days)

Adherence will be reviewed by FMT capsule return and participant diary.
Intervention code [1] 329354 0
Prevention
Comparator / control treatment
Placebo capsules will consist of microcrystalline cellulose which is encapsulated, in line with the encapsulation process used for the active FMT treatment
Control group
Placebo

Outcomes
Primary outcome [1] 339194 0
Incidence of severe diarrhea
Timepoint [1] 339194 0
Evaluated daily for 3 weeks after stem cell transplantation (HSCT)
Secondary outcome [1] 439040 0
Mean duration of severe diarrhea
Timepoint [1] 439040 0
Assessed daily for 3 weeks after HSCT
Secondary outcome [2] 439041 0
Mean diarrhea severity
Timepoint [2] 439041 0
Assessed daily for 3 weeks after HSCT
Secondary outcome [3] 439043 0
Mean stool frequency
Timepoint [3] 439043 0
Assessed daily for 3 weeks after HSCT
Secondary outcome [4] 439044 0
Incidence of treatment-emergent adverse events, including:
- Abdominal pain or discomfort
- Diarrhea
- Nausea
- Infection
Timepoint [4] 439044 0
Evaluated daily while the participant is in-patient, and weekly when discharged, for entire study duration until 30 days after final FMT capsule
Secondary outcome [5] 439045 0
Adherence to study medication defined as proportion of participants that complete full course of FMT
Timepoint [5] 439045 0
Evaluated at completion for FMT#1 (day -1, day 0 = HSCT) and at completion of FMT#2 (14 days after absolute neutrophil count (ANC) >0.8).
Secondary outcome [6] 439046 0
Incidence of fever (>38.5oC)
Timepoint [6] 439046 0
Assessed daily until 3 weeks after HSCT
Secondary outcome [7] 439047 0
Incidence of blood stream infection
Timepoint [7] 439047 0
Assessed daily for 3 weeks after HSCT
Secondary outcome [8] 439048 0
Use of supportive care medications (while in patient)
Timepoint [8] 439048 0
Supportive care usage will be extracted from medical records at any time after the participant is discharged. The latest point for extraction is 3 months after recruitment of the final participant.
Secondary outcome [9] 439049 0
Duration of hospitalisation
Timepoint [9] 439049 0
Period from starting study medication until day 30 after completion of study medication, recorded at time of discharge. At day 30 assessment (after completion of study medication), case notes will be reviewed again to confirm no other admissions after initial discharge.
Secondary outcome [10] 439050 0
Symptom burden
Timepoint [10] 439050 0
Assessed daily unit 3 weeks after HSCT
Secondary outcome [11] 439051 0
Progression free survival
Timepoint [11] 439051 0
12 and 24 months since randomisation
Secondary outcome [12] 439052 0
Overall survival
Timepoint [12] 439052 0
12 and 24 months since randomisation

Eligibility
Key inclusion criteria
1. Adult (greater or equal to 18 years of age)
2. Diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT
3. Scheduled to receive conditioning chemotherapy (+/- total body irradiation) prior to auto-HSCT
4. Able to provide written informed consent and follow all clinical trial related procedures (translator to be provided for people of culturally and linguistically diverse (CALD) backgrounds)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing gastrointestinal disease including Crohn’s disease, ulcerative colitis
2. Unable to swallow capsules
3. Pregnancy
4. Nut allergy or anaphylactic food allergy
5. Uncontrolled vomiting or oral mucositis that may impact swallowing (determined by participant) **
6. Fever (body temp >37.8oC) **

** Eligibility criteria to be reviewed before post- HSCT FMT intervention

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation table generated by trial statistician
Coded packing
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book stratified for site and conditioning therapy (HDM/BEAM)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 26990 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 26991 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 43065 0
5000 - Adelaide
Recruitment postcode(s) [2] 43066 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 317254 0
Government body
Name [1] 317254 0
National Health and Medical Research Council
Country [1] 317254 0
Australia
Funding source category [2] 317255 0
Charities/Societies/Foundations
Name [2] 317255 0
The Hospital Research Foundation Group
Country [2] 317255 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 319533 0
None
Name [1] 319533 0
None
Address [1] 319533 0
Country [1] 319533 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315990 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 315990 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 315990 0
Australia
Date submitted for ethics approval [1] 315990 0
Approval date [1] 315990 0
09/05/2024
Ethics approval number [1] 315990 0

Summary
Brief summary
The HSCT-BIOME study aims to promote gut microbiota health prior to conditioning chemotherapy and promote its stability/recovery after HSCT using encapsuled, lyophilised faecal microbiota transplantation (FMT).

Who is it for?
You may be eligible for this study if you are a male or female over the age of 18 and have been diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT.

Study details
Participants in this study will be randomised to receive either encapsulated faecal microbiota transplantation (FMT) or placebo; each given as 2 courses of 36 capsules. The first course starts before chemotherapy, aiming to boost gut microbiota health. You will be given the second course after HSCT, once your immune system has recovered.

Participants' bowel function and symptom burden will be assessed daily for 3 weeks after HSCT. Other clinical data, including how long you stay in hospital and the use of other medications to control side effects, will also be collected. Any adverse event will be constantly monitored during intervention until 30 days post FMT.

It is hoped that findings from this study will show FMT is safe and effective at reducing HSCT complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136438 0
Dr Hannah Wardill
Address 136438 0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Country 136438 0
Australia
Phone 136438 0
+61 476870643
Fax 136438 0
Email 136438 0
[email protected]
Contact person for public queries
Name 136439 0
Hannah Wardill
Address 136439 0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Country 136439 0
Australia
Phone 136439 0
+61 476870643
Fax 136439 0
Email 136439 0
[email protected]
Contact person for scientific queries
Name 136440 0
Hannah Wardill
Address 136440 0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Country 136440 0
Australia
Phone 136440 0
+61 476870643
Fax 136440 0
Email 136440 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographics (age, sex, comorbidities)
Disease and treatment variables
Primary outcome data (diarrhea)
Secondary outcome data
Gut microbiota sequencing data
When will data be available (start and end dates)?
Data will be made available when publishing the results of the primary analysis. It will remain available indefinitely.
Available to whom?
Other researchers
Available for what types of analyses?
Secondary analysis by other researchers
How or where can data be obtained?
Online data repository as specified by the journal in which the data is published. Please note it is not possible to define a specific data repository at this point.
For enquiries about data sharing and access, please contact Dr Hannah Wardill either on:
+61476870643 or [email protected] (email is preferred method of contact)


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.