Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis

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.

Study Overview

• Status: Completed
• Conditions: Radiation Enteritis

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hosipital of Digestive Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients are from Xijing Hospital.

Description

Inclusion Criteria:

1. . non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy;
2. . Patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent;
3. . able to receive follow-up examinations, follow-up examinations, and specimen retention on time;
4. . 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;

1. . Presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc;
2. . Patients who have previously undergone cholecystectomy or partial resection of the intestine;
3. . 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;
4. . Recent use of drugs that affect gastrointestinal motility;
5. . 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;
6. . Patients with mental or legal disabilities;
7. . 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;
8. . Refuse to sign informed consent;

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
chronic radiation enteritis; Non-surgically treated cervical cancer patients develop chronic radiation enteritis after radiation therapy.
No chronic radiation enteritis after radiotherapy; Patients with non-surgical cervical cancer do not develop chronic radiation enteritis after radiation therapy.
Patients with cervical cancer; Patients with cervical cancer did not undergo any treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between fecal bile acid profile and chronic radiation enteritis	Patients' fecal bile acid profiles were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry and screened for the bile acids associated with chronic radiation enteritis.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between fecal bile acid profile and intestinal microbiota in different groups.	Investigators explore the cross-talk between fecal bile acid and gut microbiota according to the results of 16s rRNA sequencing.	7 months

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 4, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Gut Microbiota; Bile Acid; Radiation Enteritis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enteritis
• Other Study ID Numbers: KY20222208-F-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No