Phase 1 Crohn's Disease and Colitis Trial, By Invitation
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
- A person must have been diagnosed with Inflammatory Bowel Disease (a condition causing long-term inflammation in the digestive tract) through a camera examination of the bowel, imaging scans, and clinical assessment.
- The person must be 3 years of age or older.
- The person must have a recurring Clostridioides difficile (C. diff) infection, or a moderate to severe C. diff infection (a type of bacterial gut infection).
- The person must have completed a medical interview and physical examination carried out by a member of the study team.
- The person must be between 3 and 21 years of age (inclusive).
- A signed consent form must be provided, and if applicable, the participant must also give their own agreement to take part (assent).
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.
- Children under 3 years of age are not eligible.
- People who have other active infections affecting the intestines are not eligible.
- People with a history of severe allergic reactions (anaphylaxis) to food are not eligible.
- Female participants aged 11 or older, or those who have already started their period, will need a urine pregnancy test on the day of the procedure — those who are pregnant will not be enrolled.
- People with severe Inflammatory Bowel Disease are not eligible.
- People who are currently using or expected to use antibiotics for a reason other than their C. diff infection are not eligible.
- People who have previously had a bad reaction to a procedure called Fecal Microbiota Transplantation (FMT) are not eligible.
- People with allergies to sodium chloride (salt) or glycerol, which are ingredients used in the procedure, are not eligible.
- People with any other condition where the treating doctor believes the treatment may pose a health risk are not eligible.
- People who are not expected to survive through the full follow-up period of the trial are not eligible.
- People who are taking high (above-normal therapeutic) doses of steroid medications are not eligible.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Number of subjects with a recurrence of C. difficile (CDI)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.