Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are able to give written consent, attend all study visits, follow study procedures, and read and write well enough to complete questionnaires for the full study period.
• People aged 18 to 80 years old at the time of signing the consent form.
• People who have been diagnosed with Crohn's disease, with symptoms that started at least 3 months before the screening visit, confirmed through medical history, ruling out infection, and findings from an endoscopy and tissue examination.
• People for whom a doctor has already decided to start treatment with infliximab or adalimumab (including biosimilar versions of these medicines).
• People who are also taking thiopurines or corticosteroids alongside their Crohn's disease treatment.

Who may not be able to join:

• People who are already taking part in another interventional clinical study.
• People who are unable to give informed consent and do not have a legal guardian to do so on their behalf.
• People with Crohn's disease affecting the area around the anus who are expected to need antibiotic treatment for this.
• People who are on long-term antibiotic treatment for any reason.
• People who currently have a fluid collection or abscess, either inside the body or around the anal area.
• People with a known allergy to the study treatment, its ingredients, or any part of the device used to deliver it.
• People with a prolonged QTc interval (an irregular heart rhythm measurement) or conditions that increase the risk of this occurring (confirm with trial site).
• People with severe chronic kidney disease, specifically stage 5 with a GFR below 10 (confirm with trial site).
• People whose Crohn's disease has led to a complication that requires surgery.
• People who are planned to be on, or are currently taking, methotrexate alongside their other treatment.
• People who have had a faecal microbiota transplant within the 8 weeks before being randomly assigned to a study group.
• People who have any other condition that, in the investigator's opinion, may affect their ability to safely participate in the study.
• People who are pregnant.
• People who have received azithromycin (an antibiotic) at any point in the previous year.
• People who have taken any antibiotic treatment within the 4 weeks before being randomly assigned to a study group.
• People who are being re-started on the same anti-TNF medication they have previously used.
• People who are on ongoing treatment with colchicine, phenytoin, or digoxin, where stopping these medicines temporarily is not possible.

Important: Always verify eligibility with the trial site directly before applying.