NCT04970446

Who might be able to join this trial:

• 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:

• 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.