Printed from Voxsanity (voxsanity.com.au) — NCT07356232 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Crohn's Disease and Colitis Trial, Not Yet Recruiting
NCT07356232
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
- The person must be able to give informed consent to participate.
- The person has a confirmed diagnosis of Crohn's disease.
- The person is planning to start one advanced Crohn's disease treatment from the following types: anti-TNF, anti-IL12/IL23, anti-IL23, anti-alpha 4 beta 7, or a JAK inhibitor.
- If the person is taking aminosalicylates, methotrexate, or thiopurines, the dose must have been stable for at least 8 weeks before the screening visit; these medications may be continued alongside the advanced therapy, and methotrexate or thiopurines may also be started within 1 week of beginning the advanced therapy.
- The person must have active disease shown by at least one condition from Group A AND at least one condition from Group B (see below).
- Group A – either: a Short Crohn's Disease Activity Index (sCDAI) score above 175 (and if taking steroid tablets, the dose must be no more than 30mg of prednisone or 9mg of budesonide); or an sCDAI score below 175 while taking 10–30mg of prednisone (or 6–9mg of budesonide) at a stable dose for 2 weeks, with a history of symptoms getting worse when trying to reduce the steroid dose in the 3 months before screening.
- Group B – at least one of: a stool test result (fecal calprotectin) of 300 or above at the start of the study; active disease seen during a bowel camera examination (colonoscopy) within 8 weeks of screening, showing scattered erosions or at least one ulcer larger than 5mm; or active disease shown on a CT scan, MRI, or ultrasound within 8 weeks of screening, with signs of inflammation such as ulceration or thickened bowel wall.
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.
- People who are pregnant or breastfeeding.
- People who have a stoma (ostomy) bag.
- People who have had their entire large bowel (colon) removed.
- People who have short gut syndrome as a result of previous surgery.
- People who have been receiving more than 350 calories per day through an intravenous (IV) drip (parenteral nutrition) in the two weeks before screening.
- People who have been following the Crohn's Disease Exclusion Diet (CDED) in the two weeks before screening.
- People who are planning to receive two advanced therapies at the same time.
- People who are planning to switch to a different medication within the same drug class as one they are currently taking (note: switching from Ustekinumab to an anti-IL23 drug is not excluded).
- People who are likely to need surgery for Crohn's disease in the near future, as judged by the investigator.
- People who have a narrowing of the bowel (stricture) causing symptoms or bowel widening greater than 3cm, as assessed by the local investigator.
- People who normally experience more than 4 very soft or liquid bowel movements per day even when feeling well.
- People who have diabetes that requires medication to manage.
- People with a known allergy to any ingredient in the Kate Farms formula.
- People who are unable to complete online surveys.
- People who are unable to receive deliveries of the partial enteral nutrition (PEN) formula.
- People who started a new Crohn's disease medication (other than steroids) in the 8 weeks before the screening visit.
- People who have not eaten any food in the 6 days before screening.
- People who are planning to start an advanced therapy at a dose that has not been approved by the FDA.
- People who are taking both prednisone and budesonide at the same time at the point of screening.
- People who have an untreated Clostridioides difficile (C. difficile) bowel infection within the last 8 weeks.
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
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Trial details
Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 April 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Rate of steroid-free remission following 8 weeks of pharmacologic therapy
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.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.