Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from 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 have been diagnosed with moderate to severe ulcerative colitis (UC), confirmed by clinical assessment, camera examination of the bowel, and/or tissue analysis, with a specific disease activity score in the moderate-to-severe range (called a modified Mayo score of 5–9), who are about to start or switch to an approved advanced medication for UC
• The advanced medications considered acceptable for this trial include anti-TNF drugs (such as infliximab, adalimumab, golimumab, or certolizumab), anti-IL-12/23 drugs (such as ustekinumab, mirikizumab, risankizumab, or guselkumab), or anti-integrin drugs (such as vedolizumab)
• People whose bowel camera examination shows moderate-to-severe inflammation (a sub-score of 2 or higher on the Mayo endoscopic scale)
• People who have at least some rectal bleeding related to their UC (a Mayo rectal bleeding sub-score of 1 or higher)
• People whose stool frequency is in the moderate-to-severe range (a Mayo stool frequency sub-score of 2 or higher)
• People aged 18 to 85 who are able to fully take part in all parts of the trial

Who may not be able to join:

• People under 18 years of age
• People who are currently pregnant, currently breastfeeding, or planning to become pregnant during the active treatment phase of the trial through natural or assisted methods (such as IVF, IUI, sperm or egg donation, or embryo transfer)
• Women who could become pregnant will be required to use highly effective contraception (with a failure rate below 1% per year when used correctly) throughout the active treatment period, unless they have had surgical sterilisation or have been postmenopausal for 2 or more years — acceptable methods include combined or progestin-only pills, the Evra patch, NuvaRing, Depo-Provera, Paragard, Mirena, Implanon, female sterilisation, or male partner sterilisation (confirm with trial site for full details)
• The trial defines postmenopausal as: 12 months without a natural period; or 6 months without a natural period plus a specific hormone blood test result (FSH at or above 40 mIU/mL); or at least 6 weeks after surgical removal of both ovaries, with or without hysterectomy (confirm with trial site)
• Male participants who are able to father children are required to avoid assisted reproduction techniques (such as IVF) during the 12-week active treatment period, and those with female partners who could become pregnant are required to use recommended contraception during that period; male participants whose partners are currently pregnant are required to use condoms during intercourse throughout the 12-week active treatment period to prevent possible drug exposure through semen
• If pregnancy occurs during the active treatment period, the participant will be withdrawn from the trial to protect the unborn baby; if pregnancy occurs during the follow-up observation period (when no active treatment is being given), the participant may be permitted to remain in the study, with visits and assessments adjusted in line with the treating doctor's pregnancy recommendations
• People with certain existing health conditions that may increase the risk of side effects, including a history of type 2 diabetes, underactive thyroid (hypothyroidism), acute or chronic kidney disease, a history of kidney transplant, or a history of infertility
• People whose baseline blood test results for kidney function, thyroid function, or liver function fall outside the normal reference ranges used by this trial — this includes specific measurements for creatinine, thyroid-stimulating hormone (TSH), liver enzymes (ALT, AST), bilirubin, and alkaline phosphatase (confirm with trial site for the exact values that apply)
• People currently taking blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, immune-affecting medications, or any other medications that may interact with selenium — a specific list of named medications applies, including but not limited to alendronate, ciprofloxacin, warfarin, eltrombopag, levofloxacin, moxifloxacin, penicillamine, and others (confirm with trial site for the full list)
• People with a known allergy to any ingredient used in the selenium supplement or the placebo used in this trial
• People with a known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, colitis related to diverticular disease, microscopic colitis, or colitis caused by an infection (such as C. difficile, CMV, or another pathogen identified by the investigator)
• People whose treating doctor or the trial investigator believes may need urgent hospitalisation or emergency bowel surgery in the near future
• People who are unwilling or unable to take the selenium supplement consistently, make dietary adjustments if needed, or attend study visits and provide biological samples as required

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