Autologous Probiotics in Patients With Defunctioning Ileostomy Following LAR for Rectal Cancer (NCT07366047) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Autologous Probiotics in Patients With Defunctioning Ileostomy Following LAR for Rectal Cancer
40 participantsStarted 2025-12-31
Plain-language summary
Rectal cancer patients who received low anterior resection combined with ileostomy may effectively reduce the probability of anastomotic leakage after surgery. However, due to the long-term semi-abandoned state of the distal colon, the probability of bowel dysfunction after ileostomy closure is very high. The incidence of low anterior resection syndrome (LARS) exceeds 70%, which is twice that of those who did not receive a preventive stoma. The main reasons include postoperative anatomical structure alteration, nerve damage, pathological changes of the colorectal mucosa, and gut microbiota variation, etc. The application of probiotics can significantly improve the bowel function of these patients. In this study, in order to enhance the colonization effect of probiotics, autologous probiotics will be applied to treat patients with defunctioning ileostomy. The primary outcome is the occurrence of major LARS after 6 months of the treatment.
Who can participate
Age range
18 Years – 80 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:
Age: 18-80years old; Curative low anterior resection for rectal cancer with defunctioning ileostomy; ileostomy closure within 3-6 month; Preoperative chemoradiotherapy ; No evidence of anastomotic leakage or severe stenosis
Exclusion Criteria:
Tumor recurrence or distant metastasis; Secondary operation with stoma; Prior disease impairing bowel function except for rectal cancer; Any contraindication for transanal irrigation; Pregnant or nursing; Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; Cognitive or psychological disorder;
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
Number of participants with major low anterior resection syndrome score (LARS score)
Timeframe: at the time of 6 months since the start of treatment
Trial details
NCT IDNCT07366047
SponsorPeking University Cancer Hospital & Institute