Phase 2 Crohn's Disease and Colitis Trial, Recruiting
Who may 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 might be able to join this trial:
- People who have been diagnosed with Crohn's Disease for at least 6 months, confirmed through accepted clinical, imaging, or laboratory methods
- People who have complex perianal fistulas (tunnels near the anal area) that have not responded to previous treatments, confirmed by examination under anaesthesia and MRI scan
- People whose Crohn's Disease in the gut itself is either not active or only mildly active, based on a standard disease activity score (CDAI of 220 or below)
- People aged 18 or older, of any sex
- People who are in generally good health based on their medical history and a physical check-up
- Women who could become pregnant must have a negative pregnancy test before joining; all participants who could father or become pregnant must use appropriate contraception as directed by the trial team
Who may not be able to join:
- People whose Crohn's Disease in the gut is currently active and needs immediate treatment
- People with a CDAI score above 220 (a measure showing more active gut disease)
- People who have never received any treatment specifically for perianal fistulas related to Crohn's Disease
- People with an abscess or fluid collection larger than 2 cm that has not been resolved beforehand
- People with narrowing of the rectum or anal area that would prevent surgery
- People currently taking steroid medications, or who have taken them in the last 4 weeks
- People with a current or past cancer diagnosis of any kind, including cancer of a fistula
- People with serious, uncontrolled conditions affecting the liver, blood, stomach or intestines (other than Crohn's), hormones, lungs, heart, nerves, or mental health
- People with immune system conditions, whether present from birth or developed later in life
- People with an allergy or medical reason they cannot receive local anaesthetic or the contrast dye used in MRI scans
- People who are unable to have an MRI scan, for example due to having a pacemaker, certain metal implants, or severe claustrophobia
- Women who are pregnant or breastfeeding
- People who cannot safely undergo anaesthesia or surgery for any reason
- People with a BMI below 18, as the procedure requires enough body fat tissue to be safely collected
- People with certain active viral infections, including HIV, HTLV I and II, Hepatitis B, Hepatitis C, or Syphilis
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: EMILIE GARRIDO PRADALIE, APHM
Phone: +33491368739
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
Where this trial is recruiting
Primary endpoints
clinically evaluated; Magnetic resonance imaging (MRI); Magnetic resonance imaging (MRI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.