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Trial registered on ANZCTR
Registration number
ACTRN12619000611123
Ethics application status
Approved
Date submitted
3/04/2019
Date registered
24/04/2019
Date last updated
21/06/2022
Date data sharing statement initially provided
24/04/2019
Date results provided
21/06/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis -(LOTUS Study)
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Scientific title
Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis - a double-blind randomised controlled trial
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Secondary ID [1]
297874
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Nil known
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Universal Trial Number (UTN)
U1111-1231-0537
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Trial acronym
LOTUS Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
312246
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Condition category
Condition code
Oral and Gastrointestinal
310793
310793
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Orally administered encapsulated lyophilised faecal microbiota transplantation administered daily over a period of 8 weeks. Given the nature of FMT, the "dose" of FMT will vary.
-Participants will be contacted weekly to check compliance and for further reminders and arranged unused product return.
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Intervention code [1]
314110
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Treatment: Other
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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
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Clinical remission and either endoscopic remission or response as determined by the total Mayo score.
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Assessment method [1]
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Timepoint [1]
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8 Weeks following commencement of FMT or placebo .
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Secondary outcome [1]
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Percentage of patients in steroid free clinical remission as defined by the partial mayo score
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Assessment method [1]
369006
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Timepoint [1]
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8 Weeks following commencement of FMT or placebo .
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Secondary outcome [2]
369007
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Percentage of patients with steroid free endoscopic remission assessed at sigmoidoscopy
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Assessment method [2]
369007
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Timepoint [2]
369007
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8 Weeks following commencement of FMT or placebo .
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Secondary outcome [3]
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Change in disease activity as assessed by CRP and faecal calprotectin
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Assessment method [3]
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Timepoint [3]
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8 Weeks following commencement of FMT or placebo
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Secondary outcome [4]
369062
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Change in IBD related quality of life as assessed by the IBD disability index
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Assessment method [4]
369062
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Timepoint [4]
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8 Weeks following commencement of FMT or placebo .
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Secondary outcome [5]
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Rates of adverse events assessed at regular intervals during study period
- Assessed through regular clinical visits, study-specific questionnaire's and clinical examination
-Possible known adverse events that will be specifically assessed are abdominal pain, bloating, change in stool frequency and fevers. Other known adverse events are not known.
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Assessment method [5]
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Timepoint [5]
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Assessed at week 1,2,3,4 and 8 following commencement of FMT or placebo .
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of ulcerative colitis of at least 3 months by standard clinical, endoscopic, and histological criteria
-Clinically and endoscopically active ulcerative colitis
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Minimum age
18
Years
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Maximum age
75
Years
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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
-Acute Severe Colitis
-Crohn's disease
-Proctitis
-Pregnancy or breast feeding
-Previous FMT treatment
-Significant medical comorbidities
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - through central randomisation
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-established computer generated randomisation list with permutated blocks of 8, stratified for study site.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Based on previous studies utilising FMT in the treatment of ulcerative colitis and allowing for 15% drop out, sample size calculated as 64 patients across both FMT and placebo groups.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
COVID-19 pandemic
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Date of first participant enrolment
Anticipated
1/05/2019
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Actual
1/08/2019
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Date of last participant enrolment
Anticipated
1/11/2020
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Actual
1/05/2020
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Date of last data collection
Anticipated
1/01/2021
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Actual
1/05/2021
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Sample size
Target
64
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Accrual to date
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Final
37
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment hospital [2]
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Concord Repatriation Hospital - Concord
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Recruitment postcode(s) [1]
26164
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
26165
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2139 - Concord
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Sydney
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Address [1]
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Corner of Eastern Avenue and City Road, Camperdown NSW 2006
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Country [1]
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
F23 Administration Building, Corner of Eastern Avenue and City Road, Camperdown NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
302296
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Country [1]
302296
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303069
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St Vincent's Hospital HREC
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Ethics committee address [1]
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St Vincent’s Hospital Translational 97-105 Boundary Street Darlinghurst NSW 2010
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
303069
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Approval date [1]
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13/03/2019
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Ethics approval number [1]
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HREC/18/SVH/219
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Summary
Brief summary
Ulcerative colitis (UC) is a chronic, disabling immune mediated inflammatory condition affecting the large bowel, which is thought to be caused by an aberrant interaction between the immune system and a dysbiotic intestinal microbiome. There is emerging evidence that faecal microbiota transplantation (FMT) is effective in treating UC. This is a multi-centre double blind, randomised, placebo-controlled trial of orally administered FMT in patients with chronic active UC over an 8 week period.
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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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Prof Rupert Leong
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Address
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Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord, NSW 2109
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Country
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Australia
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Phone
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+61 (02) 67676111
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Fax
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Email
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FMTinUC@gmail.com
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Contact person for public queries
Name
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Craig Haifer
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Address
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Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord, NSW 2109
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Country
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Australia
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Phone
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+61 (02) 67676111
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Fax
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Email
92359
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fmtinuc@gmail.com
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Contact person for scientific queries
Name
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Craig Haifer
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Address
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Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord,NSW, 2109
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Country
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Australia
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Phone
92360
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+61 (02) 67676111
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Fax
92360
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Email
92360
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fmtinuc@gmail.com
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Data will be analysed in a group
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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
Source
Title
Year of Publication
DOI
Embase
Lyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial.
2022
https://dx.doi.org/10.1016/S2468-1253%2821%2900400-3
Embase
Microbial determinants of effective donors in faecal microbiota transplantation for UC.
2023
https://dx.doi.org/10.1136/gutjnl-2022-327742
Embase
The microbiome in HLA-B27-associated disease: implications for acute anterior uveitis and recommendations for future studies.
2023
https://dx.doi.org/10.1016/j.tim.2022.08.008
N.B. These documents automatically identified may not have been verified by the study sponsor.
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