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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
17/02/2020
Date data sharing statement initially provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis -(LOTUS Study)
Scientific title
Lyophilised Oral Faecal Microbiota Transplantation in the Management of Ulcerative Colitis - a double-blind randomised controlled trial
Secondary ID [1] 297874 0
Nil known
Universal Trial Number (UTN)
U1111-1231-0537
Trial acronym
LOTUS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
312246 0
Condition category
Condition code
Oral and Gastrointestinal 310793 310793 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314110 0
Treatment: Other
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] 319644 0
Clinical remission and either endoscopic remission or response as determined by the total Mayo score.
Timepoint [1] 319644 0
8 Weeks following commencement of FMT or placebo .
Secondary outcome [1] 369006 0
Percentage of patients in steroid free clinical remission as defined by the partial mayo score
Timepoint [1] 369006 0
8 Weeks following commencement of FMT or placebo .
Secondary outcome [2] 369007 0
Percentage of patients with steroid free endoscopic remission assessed at sigmoidoscopy
Timepoint [2] 369007 0
8 Weeks following commencement of FMT or placebo .
Secondary outcome [3] 369061 0
Change in disease activity as assessed by CRP and faecal calprotectin
Timepoint [3] 369061 0
8 Weeks following commencement of FMT or placebo
Secondary outcome [4] 369062 0
Change in IBD related quality of life as assessed by the IBD disability index
Timepoint [4] 369062 0
8 Weeks following commencement of FMT or placebo .
Secondary outcome [5] 369063 0
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.
Timepoint [5] 369063 0
Assessed at week 1,2,3,4 and 8 following commencement of FMT or placebo .

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
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Acute Severe Colitis
-Crohn's disease
-Proctitis
-Pregnancy or breast feeding
-Previous FMT treatment
-Significant medical comorbidities

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - through central randomisation
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.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
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.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13541 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 13542 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 26164 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 26165 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 302399 0
University
Name [1] 302399 0
University of Sydney
Address [1] 302399 0
Corner of Eastern Avenue and City Road, Camperdown NSW 2006
Country [1] 302399 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
F23 Administration Building, Corner of Eastern Avenue and City Road, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 302296 0
None
Name [1] 302296 0
Address [1] 302296 0
Country [1] 302296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303069 0
St Vincent's Hospital HREC
Ethics committee address [1] 303069 0
St Vincent’s Hospital Translational
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 303069 0
Australia
Date submitted for ethics approval [1] 303069 0
Approval date [1] 303069 0
13/03/2019
Ethics approval number [1] 303069 0
HREC/18/SVH/219

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92358 0
Prof Rupert Leong
Address 92358 0
Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord, NSW 2109
Country 92358 0
Australia
Phone 92358 0
+61 (02) 67676111
Fax 92358 0
Email 92358 0
FMTinUC@gmail.com
Contact person for public queries
Name 92359 0
Dr Craig Haifer
Address 92359 0
Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord, NSW 2109
Country 92359 0
Australia
Phone 92359 0
+61 (02) 67676111
Fax 92359 0
Email 92359 0
fmtinuc@gmail.com
Contact person for scientific queries
Name 92360 0
Dr Craig Haifer
Address 92360 0
Concord Repatriation General Hospital
Gastroenterology Department
Hospital Rd, Concord,NSW, 2109
Country 92360 0
Australia
Phone 92360 0
+61 (02) 67676111
Fax 92360 0
Email 92360 0
fmtinuc@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed in a group
What supporting documents are/will be available?
No other documents available
Summary results
No Results