Trial Review

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
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 information initially provided
9/12/2020
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
Sex
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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19 pandemic
Date of first participant enrolment
Anticipated
1/05/2019
Actual
1/08/2019
Date of last participant enrolment
Anticipated
1/11/2020
Actual
1/05/2020
Date of last data collection
Anticipated
1/01/2021
Actual
1/05/2021
Sample size
Target
64
Accrual to date
Final
37
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
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
[email protected]
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
[email protected]
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
[email protected]

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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Haifer C, Paramsothy S, Kaakoush NO, Saikal A, Gha... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMicrobial determinants of effective donors in faecal microbiota transplantation for UC.2023https://dx.doi.org/10.1136/gutjnl-2022-327742
EmbaseThe microbiome in HLA-B27-associated disease: implications for acute anterior uveitis and recommendations for future studies.2023https://dx.doi.org/10.1016/j.tim.2022.08.008
EmbaseLyophilised oral faecal microbiota transplantation for ulcerative colitis (LOTUS): a randomised, double-blind, placebo-controlled trial.2022https://dx.doi.org/10.1016/S2468-1253%2821%2900400-3
N.B. These documents automatically identified may not have been verified by the study sponsor.