Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis (NCT05728060) | Clinical Trial Compass
CompletedNot Applicable
Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
China60 participantsStarted 2022-12-01
Plain-language summary
To explore the fecal bile acid profile of patients with radiation enteritis, to clarify the types of bile acids that are closely related to the occurrence of radiation enteritis; to explore the interaction between fecal bile acids and intestinal flora in patients with radiation enteritis, and to lay the foundation for further elucidation of the pathogenesis of radiation enteritis.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
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
. . non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy;
. . Patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent;
. . able to receive follow-up examinations, follow-up examinations, and specimen retention on time;
. . The case group met the diagnostic criteria for chronic radiation enteritis in the "Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis in China (2018 edition)"; Control group 1: Non-surgical cervical cancer patients without chronic radiation enteritis after radiotherapy; Control group 2: Patients with cervical cancer who did not receive any treatment.
Exclusion criteria
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
Correlation between fecal bile acid profile and chronic radiation enteritis
. . Presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc;
. . Patients who have previously undergone cholecystectomy or partial resection of the intestine;
. . Taking drugs affecting bile acid metabolism due to other diseases, such as cholestyramine, anti-inflammatory and Xiaoyan lidan tablets, Danshu capsules, ursodeoxycholic acid, obeticholic acid, and proprietary Chinese medicines such as schisandrin B, Tanshinone IIA, and Yinjiazhuang;
. . Recent use of drugs that affect gastrointestinal motility;
. . Patients with moderate or severe renal impairment (blood creatinine \> 2 mg/dL or 177 mmol/L), or abnormal liver function (ALT \> 2 times the upper limit of normal value); moderate or severe chronic obstructive pulmonary disease; patients with severe hypertension, patients with cerebrovascular accidents; patients with congestive heart failure, unstable angina pectoris;
. . Patients with mental or legal disabilities;
. . Suspected or confirmed history of alcohol/substance abuse or other pathology that, in the judgment of the investigator, reduces the likelihood of enrollment or complicates enrollment;