Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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)
Query!
Secondary ID [1]
312816
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
HSCT-BIOME
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
myeloma
334898
0
Query!
lymphoma
334899
0
Query!
blood cancer
334900
0
Query!
Condition category
Condition code
Cancer
331444
331444
0
0
Query!
Myeloma
Query!
Cancer
331445
331445
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
331446
331446
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329354
0
Prevention
Query!
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
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
339194
0
Incidence of severe diarrhea
Query!
Assessment method [1]
339194
0
Stool frequency (>/=4/day), consistency (as determined using Bristol Stool Char score 6+t) and duration (>/=3 consecutive days) collected from daily bowel movement reported from participant to research nurse (while in patient), and from participant diaries when discharged.
Query!
Timepoint [1]
339194
0
Evaluated daily for 3 weeks after stem cell transplantation (HSCT)
Query!
Secondary outcome [1]
439040
0
Mean duration of severe diarrhea
Query!
Assessment method [1]
439040
0
Bristol stool chart score 6+
Query!
Timepoint [1]
439040
0
Assessed daily for 3 weeks after HSCT
Query!
Secondary outcome [2]
439041
0
Mean diarrhea severity
Query!
Assessment method [2]
439041
0
Bristol stool chart
Query!
Timepoint [2]
439041
0
Assessed daily for 3 weeks after HSCT
Query!
Secondary outcome [3]
439043
0
Mean stool frequency
Query!
Assessment method [3]
439043
0
Participant reported number of bowel movements / 24 hours
Query!
Timepoint [3]
439043
0
Assessed daily for 3 weeks after HSCT
Query!
Secondary outcome [4]
439044
0
Incidence of treatment-emergent adverse events, including:
- Abdominal pain or discomfort
- Diarrhea
- Nausea
- Infection
Query!
Assessment method [4]
439044
0
CTCAE v5.0
Query!
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
Query!
Secondary outcome [5]
439045
0
Adherence to study medication defined as proportion of participants that complete full course of FMT
Query!
Assessment method [5]
439045
0
Participant diaries and capsule counts
Query!
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).
Query!
Secondary outcome [6]
439046
0
Incidence of fever (>38.5oC)
Query!
Assessment method [6]
439046
0
Body temperature taken from ear
Query!
Timepoint [6]
439046
0
Assessed daily until 3 weeks after HSCT
Query!
Secondary outcome [7]
439047
0
Incidence of blood stream infection
Query!
Assessment method [7]
439047
0
Blood culture
Query!
Timepoint [7]
439047
0
Assessed daily for 3 weeks after HSCT
Query!
Secondary outcome [8]
439048
0
Use of supportive care medications (while in patient)
Query!
Assessment method [8]
439048
0
Clinical case note review
Query!
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.
Query!
Secondary outcome [9]
439049
0
Duration of hospitalisation
Query!
Assessment method [9]
439049
0
Days in hospital
Query!
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.
Query!
Secondary outcome [10]
439050
0
Symptom burden
Query!
Assessment method [10]
439050
0
ESAS-R-CS
Query!
Timepoint [10]
439050
0
Assessed daily unit 3 weeks after HSCT
Query!
Secondary outcome [11]
439051
0
Progression free survival
Query!
Assessment method [11]
439051
0
Clinical case note review (identifying relapse and/or death)
Query!
Timepoint [11]
439051
0
12 and 24 months since randomisation
Query!
Secondary outcome [12]
439052
0
Overall survival
Query!
Assessment method [12]
439052
0
Clinical case note review to identify death
Query!
Timepoint [12]
439052
0
12 and 24 months since randomisation
Query!
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)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation table generated by trial statistician
Coded packing
Query!
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)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
1/11/2024
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/12/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2028
Query!
Actual
Query!
Sample size
Target
51
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA
Query!
Recruitment hospital [1]
26990
0
The Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [2]
26991
0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Query!
Recruitment postcode(s) [1]
43065
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
43066
0
2010 - Darlinghurst
Query!
Funding & Sponsors
Funding source category [1]
317254
0
Government body
Query!
Name [1]
317254
0
National Health and Medical Research Council
Query!
Address [1]
317254
0
Query!
Country [1]
317254
0
Australia
Query!
Funding source category [2]
317255
0
Charities/Societies/Foundations
Query!
Name [2]
317255
0
The Hospital Research Foundation Group
Query!
Address [2]
317255
0
Query!
Country [2]
317255
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Central Adelaide Local Health Network
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319533
0
None
Query!
Name [1]
319533
0
None
Query!
Address [1]
319533
0
Query!
Country [1]
319533
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315990
0
Central Adelaide Local Health Network HREC
Query!
Ethics committee address [1]
315990
0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Query!
Ethics committee country [1]
315990
0
Australia
Query!
Date submitted for ethics approval [1]
315990
0
Query!
Approval date [1]
315990
0
09/05/2024
Query!
Ethics approval number [1]
315990
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
136438
0
Dr Hannah Wardill
Query!
Address
136438
0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Query!
Country
136438
0
Australia
Query!
Phone
136438
0
+61 476870643
Query!
Fax
136438
0
Query!
Email
136438
0
[email protected]
Query!
Contact person for public queries
Name
136439
0
Hannah Wardill
Query!
Address
136439
0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Query!
Country
136439
0
Australia
Query!
Phone
136439
0
+61 476870643
Query!
Fax
136439
0
Query!
Email
136439
0
[email protected]
Query!
Contact person for scientific queries
Name
136440
0
Hannah Wardill
Query!
Address
136440
0
South Australian Health and Medical Research Institute (SAHMRI), North Terrace, Adelaide, 5000 South Australia
Query!
Country
136440
0
Australia
Query!
Phone
136440
0
+61 476870643
Query!
Fax
136440
0
Query!
Email
136440
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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
Query!
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.
Query!
Available to whom?
Other researchers
Query!
Available for what types of analyses?
Secondary analysis by other researchers
Query!
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)
Query!
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.
Download to PDF