Azathioprine Linked With Impaired Intestinal Epithelial Postoperative Regeneration in Crohn's Dis… (NCT05456776) | Clinical Trial Compass
CompletedNot Applicable
Azathioprine Linked With Impaired Intestinal Epithelial Postoperative Regeneration in Crohn's Disease
35 participantsStarted 2014-04
Plain-language summary
What is known?
* the impact of AZA, immunomodulatory drug widely used in active CD, on the intestinal wall differs from those of steroids, what is reflected in the significant difference in the postoperative anastomotic leaks rate
* AZA inhibits intestinal epithelial cell growth by inducing the apoptosis and inhibiting proliferation of intestinal epithelial cells in in vitro studies What is new?
* The effect of AZA on cellular damage was assessed in humans' study
* AZA increases cell apoptosis in the intestinal epithelium of active CD patients, much stronger than steroids
* AZA actively promotes the DNA damage repair in the intestinal epithelium; the steroid effect, even when combined with AZA, is not so pronounced
* The intensity of proliferative processes, in contrast to steroids, is significantly inhibited in response to AZA
* The disintegration of the mucosa layer in response to AZA is observed
* The difference in the mechanisms of action of AZA and steroids on the intestinal mucosa may be directly related to the reported difference in the risk of septic postoperative complications, but this requires further research
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* diagnosed with histopathologically confirmed CD at least six months earlier, operated due to active disease characterised by clinical, endoscopical, and radiological findings
* ileocecal involvement
* No other CD manifestations
* Signed informed consent
Exclusion Criteria:
* Previous bowel surgery for CD
* Presence of severe, progressive, uncontrolled cardiological, pulmonary, nephrology, contagious or psychiatric illness whose course could affect the patient's risk of perioperative complications
* Significant disease symptoms so far undiagnosed
* Present or suspected malignancy or previous oncological treatment in the last five years
* Cardiac stimulator or cardioverter-defibrillator
* Pregnancy
* Severe non-abdominal surgery or severe trauma in the last year
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
histopathological assessment of the azathioprine's impact on intestinal damage