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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000914763

Enrollment

Registered

2022-06-27

Start date

2023-09-11

Completion date

2024-06-01

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

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

Outcome results