Phase 2 Crohn's Disease and Colitis Trial, Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been diagnosed with active Crohn's disease that has been confirmed by a camera test (endoscopy) showing active inflammation within the last 6 months — or, if your disease is in a part of the small bowel that can't be reached by endoscopy, an ultrasound scan showing inflammation is acceptable instead.
- Your Crohn's disease activity score (a measurement of your symptoms called CDAI) falls between 220 and 450.
- You have at least one of the following signs of inflammation: a raised CRP blood test result (5mg/L or above), a raised stool test result called faecal calprotectin (100μg/g or above), or signs of inflammation seen on an ultrasound or MRI scan.
- You are willing and able to visit the study sites regularly for camera (endoscopy) procedures.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have active disease around the anal area or have tunnels/passages (fistulas) caused by Crohn's disease.
- You are pregnant or planning to become pregnant within the next 12 months.
- You have a gut or bowel condition other than Crohn's disease causing inflammation.
- You have a narrowing (stricture) in your bowel that is causing symptoms and is likely to need surgery.
- You have a stoma (a surgically created opening on your abdomen for waste).
- You have had a surgical pouch created as part of bowel surgery (ileoanal pouch).
- Your white blood cell count is too low (below 3.0 x 10⁹/L) (confirm with trial site).
- Your albumin (a protein measured in your blood) level is below 20g/L, which may indicate poor nutrition (confirm with trial site).
- You have a weakened immune system for reasons other than medications taken for your Crohn's disease — for example, HIV or a condition called Common Variable Immune Deficiency.
- You have a history of severe allergic reactions (anaphylaxis) to food.
- Your dose of certain Crohn's medications — including thiopurines, methotrexate, biologic treatments, small molecule inhibitors, or aminosalicylates — has been changed too recently before joining the study (the exact timeframes vary by medication, so confirm with the trial site).
- You have used prebiotics, probiotics, antibiotics, or over-the-counter supplements in the two weeks before joining the study.
- You have used rectal (back passage) treatments for Crohn's disease in the two weeks before joining the study.
- You are taking a steroid dose higher than the permitted level (prednisolone above 20mg or budesonide above 6mg).
- You are unwilling or unable to gradually reduce and stop corticosteroid (steroid) medications within 8 weeks of the start of the treatment being studied.
- You currently have an active infection in your gut or digestive system.
- You drink alcohol at a dependent level.
- You have a liver condition called primary sclerosing cholangitis.
- Your gastroenterologist (gut specialist) believes there is any reason that taking part could put your health at risk (confirm with trial site).
- The medical team feels you are not able to safely take part in the treatment being studied (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Michael A Kamm, MD, St Vincents Hospital
Phone: 0392311352
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Clinical response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.