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Trial registered on ANZCTR
Registration number
ACTRN12625000374460
Ethics application status
Approved
Date submitted
26/03/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Microbiome in Transplant and Cellular Therapy Outcomes.
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Scientific title
Gastrointestinal microbiome influences health outcomes in patients undergoing Transplantation and Cellular Therapy.
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Secondary ID [1]
313886
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None
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Universal Trial Number (UTN)
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Trial acronym
micro TCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Immune system function
336557
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Gastrointestinal (GI) microbiome interaction post-therapy/transplant
336555
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Antimicrobial Resistance (AMR)
336556
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Graft-Versus-Host-Disease (GVHD)
336554
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Condition category
Condition code
Metabolic and Endocrine
333072
333072
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0
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Normal metabolism and endocrine development and function
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Inflammatory and Immune System
333071
333071
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0
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Autoimmune diseases
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Inflammatory and Immune System
333070
333070
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0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This observational study involves the collection from each time point (below): Blood samples, rectal swabs, frozen stool and bronchoalveolar lavage/ wash samples, processed and stored whole or as derivatives. To help us define the interaction between the microbiome and the outcomes of participants' transplant or cellular therapy.
Clinical information and samples will be collected prospectively at the following timepoints for participants receiving Hematopoietic Stem Cell Transplantation (HSCT):
- The day of patients transplant (Day 0);
- Day 14 post-transplant;
- Day of hospital discharge; and
- Day 100
Participants who receive HSCT, are also invited to undergo the optional PET-scan at Day 14-18 post-transplant, and may be invited for a repeat scan if they are readmitted with GVHD.
Patients who receive Chimeric Antigen Receptor (CAR) T/Natural Killer (NK) cellular therapy will have samples collected:
- Day of infusion;
- Day 14;
- Day 30 and;
- Day 100 post-infusion
For patients that receive Solid Organ Transplantation, will have samples collected:
- Prior to their scheduled transplant (Day of Listing on this study)
- Day of transplant;
- Day of hospital discharge post-transplant;
- Day 21 post-transplant procedure;
- Day 90 post-transplant;
- 6 months post-transplant; and
- 12 months post-transplant
Participants may also be invited to donate samples if they are readmitted to hospital with an infection, or GVHD.
Participants enrolled in this study will also have clinical information collected (if consented) during their collection timepoints and at Month 6 and 12 post-transplant/infusion check-ups. This may include disease indication, characteristics of Transplant and Cellular Therapy (TCT), incidence of acute toxicities and disease response, and incidence of longer-term complications, survival and episodes of Infection, GVHD and organ rejection. As well as the collection of information regarding other indirect complications of TCT, including but not limited to GVHD, infectious complications, immunological complications, duration of hospitalization and use of concurrent medications
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Intervention code [1]
330487
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Early Detection / Screening
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To characterise the composition and diversity of the Gastrointestinal (GI) Microbiome in Transplant and Cellular Therapy (TCT) patients.
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Assessment method [1]
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Faecal bacterial sequencing, faecal microbial metabolite and metabolomic measurement, and Metabolite analysis.
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Timepoint [1]
341045
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Participants who receive CAR T/NK therapy or HSCT will have a rectal swab, and solid stool sample analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants who receive Solid Organ Transplantation (SOT) will have faecal samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants may also be invited to have additional samples collected if readmitted while enrolled in the study.
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Primary outcome [2]
340801
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To characterise the Intestinal microbial composition outcomes following transplantation and cellular therapies.
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Assessment method [2]
340801
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Rectal swabs will be ran in batched shotgun metagenomic sequencing and MetaPanel analysis. Stool samples from Cohort 1, will undergo bacterial sequencing using a novel technique, i.e., IgA-LongReadSeq. Coupled with long-read sequencing to output quality genomic analysis. Metabolite and metabolomic analysis of stool and blood samples will be performed using high accuracy orbitrap mass spectrometry and a highly curated subset of relevant metabolites
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Timepoint [2]
340801
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Participants who receive CAR T/NK cellular therapy or Hematopoietic Stem Cell Transplantation (HSCT) will have their faecal (rectal swab and solid stool) samples analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or Graft-versus-Host-Disease (GVHD) while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have faecal samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplant. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
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Primary outcome [3]
341047
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Measurement and characterisation of Short Chain Fatty Acid (SCFA) levels in participant's biological samples
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Assessment method [3]
341047
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SCFA will be obtained via collected biological samples (e.g., stool, blood plasma/serum); Faecal bacterial sequencing, faecal microbial metabolite and metabolomic measurement, Bronchiolar lavage bacterial sequencing, blood SCFA and Metabolite analysis
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Timepoint [3]
341047
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Participants who receive CAR T/NK therapy or HSCT will have their blood and stool samples analysed from the timepoint: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and Bronchial Wash samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
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Secondary outcome [1]
445949
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Primary Outcome: Characterising the interaction of immune function in TCT patients
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Assessment method [1]
445949
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Assessment may include but not be limited to immune markers and immune cell populations, such as cytokine profiles from blood samples.
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Timepoint [1]
445949
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Participants who receive CAR T/NK therapy or HSCT will have their blood and stool samples analysed from the timepoint: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study. Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and Bronchial Wash samples collected at differing timepoints: Day of listing, Day of transplant, Day of discharge from the hospital, Day 21, and 90 post-transplant, and Month 6 and 12 post-transplants. Participants who receive SOT will also be invited to donate samples if they are readmitted while enrolled in the study.
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Secondary outcome [2]
445950
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Clinical information/outcomes will be collected to categorize and correlate TCT patient responses to their transplant or cellular therapy.
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Assessment method [2]
445950
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Clinical information/outcome of participants will involve composite correlation of their Disease indication, characteristics of HSCT/CAR-T/SOT, incidence of acute toxicities and disease response, and incidence of longer-term complications, survival and episodes of Infection, GVHD and organ rejection. This will include collection of information regarding other indirect complications of TCT including but not limited to GVHD, infectious complications, immunological complications, duration of hospitalization and use of concurrent medications. This clinical annotation of samples will provide insight into patient groups with the highest rates of complications, and identification of factors linked to clinical outcome
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Timepoint [2]
445950
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A baseline dataset plus specified clinical information will be collected at each time point, as well as 6 and 12 months post-procedure. If novel scientific findings prompt requirement for additional clinicopathological correlation, clinical data may be obtained from the participant’s medical record.
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Secondary outcome [3]
445230
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To evaluate the accuracy of integrated, comprehensive multiomics analyses in predicting GI-GVHD, compared to clinical information and patient outcomes obtained throughout their enrolment.
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Assessment method [3]
445230
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Metagenomic microbial sequencing, measurement of microbe-derived metabolites, immune cell enumeration and phenotyping and FDG-PET analyses.
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Timepoint [3]
445230
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Participants who receive CAR T/NK cellular therapy or HSCT will have their blood and stool samples analysed from the timepoints: Day 0 (day of infusion/transplantation), Day 14, Day 30 or day of hospital discharge, and Day 100. Participants may also be invited to have additional samples collected if readmitted with Infection and/or GVHD while enrolled in the study.
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Secondary outcome [4]
445231
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To detect and monitor the carriage of AMR genes and pathogens over time in the intestinal microbiota of transplant and cellular therapy patients
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Assessment method [4]
445231
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Clinical data obtained from your medical records which include transplant type, antibiotic use and infections experienced will be collected and analysed. Where AMR genes are detected by faecal sequencing, additional samples may be collected at the next available sample timepoint for culture.
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Timepoint [4]
445231
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If participants are found to have AMR genes/pathogens while enrolled in the study, samples will be collected at their next scheduled timepoint of specimen collection. If participants are readmitted to hospital, while enrolled, they may be asked by the investigator to donate blood and stool samples when convenient.
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Secondary outcome [5]
445232
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To characterise lung microbiome outcomes in solid organ transplant patients.
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Assessment method [5]
445232
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Clinicopathological correlation, Bronchiolar Lavage bacterial sequencing, Immune and Cellular Analysis, Faecal metagenomic sequencing and MetaPanel analysis, and Faecal Microbial Metabolite and Metabolomic Measurement.
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Timepoint [5]
445232
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Participants who receive Solid Organ Transplantation (SOT) will have blood, faecal, and/or Bronchial Wash samples collected at the following timepoints: - Day of listing, - Day of transplant, - Day of discharge from the hospital, - Day 21, and 90 post-transplant, and - Month 6 and 12 post-transplant. Participants who receive SOT will also be invited to have samples collected if they are readmitted to hospital while enrolled in the study.
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Eligibility
Key inclusion criteria
- Age 18 years or older;
- Able to provide voluntary informed consent;
- Planned administration of allogeneic HSCT, CAR T/NK or SOT.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Unwilling or unable to undertake specific components of the study, such as:
- Venepuncture;
- Provision of faecal specimens;
- Rectal swab
2. Allergy/intolerance to FDG; these subjects may still be enrolled for specimen provision but abstain from the FDG-PET component.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/05/2025
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Actual
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Date of last participant enrolment
Anticipated
29/12/2028
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Actual
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Date of last data collection
Anticipated
30/03/2029
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
27658
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [2]
27659
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The Prince Charles Hospital - Chermside
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Recruitment postcode(s) [1]
43833
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4032 - Chermside
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Recruitment postcode(s) [2]
43832
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
318370
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Government body
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Name [1]
318370
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NHMRC Ideas Grant
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Address [1]
318370
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Country [1]
318370
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Australia
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Funding source category [2]
318355
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Government body
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Name [2]
318355
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Department of Health and Aged Care: Medical Research Future Fund (MRFF)
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Address [2]
318355
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Country [2]
318355
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Australia
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Primary sponsor type
Government body
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Name
Metro North Hospital and Health Service (MNHHS)
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Address
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Country
Australia
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Secondary sponsor category [1]
320769
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None
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Name [1]
320769
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Address [1]
320769
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Country [1]
320769
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316986
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Metro North Health Human Research Ethics Committee
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Ethics committee address [1]
316986
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
316986
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Australia
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Date submitted for ethics approval [1]
316986
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Approval date [1]
316986
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08/01/2025
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Ethics approval number [1]
316986
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Summary
Brief summary
This study will assess multiomics of intestinal microbial composition and the relationship with other metabolic components, including short-chain fatty acids (SCFA) and immune cell function, which will inform for improvements of health outcomes in Transplant and Cellular Therapy recipients.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Andrea Henden
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Address
139662
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Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
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Country
139662
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Australia
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Phone
139662
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+61736461340
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Fax
139662
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Email
139662
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[email protected]
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Contact person for public queries
Name
139663
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Andrea Henden
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Address
139663
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Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
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Country
139663
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Australia
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Phone
139663
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+61736461340
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Fax
139663
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Email
139663
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[email protected]
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Contact person for scientific queries
Name
139664
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Andrea Henden
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Address
139664
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Royal Brisbane and Women's Hospital. Butterfield St, Herston 4006 QLD.
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Country
139664
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Australia
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Phone
139664
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+61736461340
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Fax
139664
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Email
139664
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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