ANZCTR - Registration

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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

ACTRN12622000914763

Ethics application status

Approved

Date submitted

19/06/2022

Date registered

27/06/2022

Date last updated

19/10/2023

Date data sharing statement initially provided

27/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Orally Administered Faecal Microbial Transplantation in the Management of Immune Checkpoint Inhibitor Associated Colitis

Scientific title

Orally Administered Faecal Microbial Transplantation in the Management of Immune Checkpoint Inhibitor Associated Colitis - A randomised control trial to assess safety and preliminary efficacy

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Immune Checkpoint inhibitor Colitis

Condition category

Condition code

Cancer

Other cancer types

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Orally administered encapsulated lyophilised faecal microbiota transplantation(FMT) administered daily over a period of 7 days. Given the nature of FMT, the "dose" of FMT will vary.
Participants will be contacted throughout the trial period to check compliance and for further reminders and arranged unused product return.

Intervention code [1]

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]

Percentage of patients in clinical remission as determined by stool count. through a patient diary

Timepoint [1]

1 week following commencement of FMT or placebo

Secondary outcome [1]

Percentage of patients in clinical remission as determined by the stool count through a patient diary

Timepoint [1]

Week 2, 4, 8 and 12 following commencement of FMT or placebo

Secondary outcome [2]

Percentage of patients in clinical response as determined by the stool count through a patient diary

Timepoint [2]

Week 1,2,4,8 and 12 following commencement of FMT or placebo

Secondary outcome [3]

Percentage of patients on corticosteroids assessed through a study-specific questionnaire and medical records

Timepoint [3]

Week 2,4,6 and 12 following commencement of FMT or placebo

Secondary outcome [4]

Median duration of corticosteroids assessed through a study-specific questionnaire and medical records

Timepoint [4]

Week 12 following commencement of FMT or placebo

Secondary outcome [5]

Cumulative dose of corticosteroids assessed through a study-specific questionnaire and medical records

Timepoint [5]

Week 12 following commencement of FMT or placebo

Secondary outcome [6]

Percentage of patients able to recommence immunotherapy assessed through a study-specific questionnaire and medical records

Timepoint [6]

Week 12 following commencement of FMT or placebo

Secondary outcome [7]

Change in disease activity determined by blood and stool biomarkers (C-reactive protein, faecal calprotectin)

Timepoint [7]

Week 1, 2,4,8 and 12 following commencement of FMT or placebo

Secondary outcome [8]

Rates of adverse events assessed through study-specific questionnaire, clinical examination and medical records.. Examples of possilbe adverse events include gastrointestinal upset, worsening colitis, transient fevers and very low risk of transmissible infection,

Timepoint [8]

Week 1,2,4,8 and 12 following commencement of FMT or placebo

Secondary outcome [9]

Change in patient reported outcomes assessed using PRO-2 score through a study-specific questionnaire

Timepoint [9]

Week 1,2,4,8 and 12 following commencement of FMT or placebo

Eligibility

Key inclusion criteria

• Grade 2 or more diarrhoea (greater than 4 bowel actions more than baseline)
• Last dose of checkpoint inhibitor within 4 months of symptom onset

Either
• No response to oral glucocorticoids
OR
• Steroid intolerant
OR
• Recurrence of symptoms during or following corticosteroid wean
Or
• Recurrent episode of immune checkpoint inhibitor colitis.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Infective colitis
-Inflammatory bowel disease
-Previous colectomy
-Significant medical comorbidity

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)

Through central randomisation by computer generated list.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Pre-established computer generated randomisation list.

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

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Based on previous studies using FMT in the treatment of ICI colitis and allowing for 10% drop out,s ample size calculated as 46 patients across FMT and placebo groups

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/12/2022

Actual

11/09/2023

Date of last participant enrolment

Anticipated

1/06/2024

Actual

Date of last data collection

Anticipated

1/09/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment postcode(s) [1]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital Sydney

Address [1]

390 Victoria St, Darlinghurst, NSW, 2010

Country [1]

Australia

Primary sponsor type

Hospital

Name

St Vincent's Hospital Sydney

Address

390 Victoria St, Darlinghurst, NSW, 2010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital HREC

Ethics committee address [1]

St Vincent’s Hospital Translational
97-105 Boundary Street
Darlinghurst NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/06/2022

Approval date [1]

20/07/2022

Ethics approval number [1]

Summary

Brief summary

Cancer immunotherapy with immune checkpoint inhibitors (ICI) have revolutionised the treatment and outcomes for multiple cancers in the past 10 years leading to sustained remission and cure in some patients even when diagnosed with advanced disease. However, immune mediated side effects are common including diarrhoea and colitis which can affect up to 40% of patients who take ICI's. This study aims to assess whether a short course (7 days) of oral treatment with faecal microbiota transplantation (FMT) therapy has any impact upon ICI colitis symptoms in patients who are affected by this.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or older, you have experienced diarrhoea from your ICI and your last dose was within 4 months of symptom onset. Participants who are steroid intolerant, have had no response to oral glucocorticoids, have had recurrence of symptoms during or following corticosteroid wean or have had recurrent episodes of immune checkpoint inhibitor colitis will be considered for inclusion.

Study details
All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the FMT group or a placebo group. Both groups will be asked to take FMT capsules each day for 7 days, and to keep a diary of their bowel movements for up to 12 weeks after enrolling in the study. Participants will also be asked to provide stool and blood samples throughout the study and may also require a colonoscopy. The overall participation will be 12 weeks.

It is hoped this research will demonstrate that it is safe and effective to use orally administered FMT to treat ICI colitis in cancer patients who have been taking immune checkpoint inhibitors. If FMT is successful, this may lead to a reduction in overall corticosteroid use, hospitalisation and an early resumption of their cancer immunotherapy for affected patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Craig Haifer

Address

Gastroenterology Department, St Vincent's Hospital 390 Victoria St Darlinghurst, NSW, 2010

Country

Australia

Phone

+61 2 83822061

Fax

[email protected]

Contact person for public queries

Name

Craig Haifer

Address

Gastroenterology Department, St Vincent's Hospital 390 Victoria St Darlinghurst, NSW, 2010

Country

Australia

Phone

+61 2 83822061

Fax

[email protected]

Contact person for scientific queries

Name

Craig Haifer

Address

Gastroenterology Department, St Vincent's Hospital 390 Victoria St Darlinghurst, NSW, 2010

Country

Australia

Phone

+61283822061

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Data will be analysed as a group

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.

Trial Review

Documents added manually

Documents added automatically