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

NCT05728060 | Completed

• 1 other identifier: KY20222208-F-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radiation Enteritis

Keywords

Radiation Enteritis; Bile Acid; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between fecal bile acid profile and intestinal microbiota in different groups.

  7 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are from Xijing Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Refuse to sign informed consent;

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• Shen X, Li SB, Gao MJ, Cao JJ, Yang H, Li WW, Wei LC, Chen M, Liu JY, Shi YQ. Relationship Between Fecal Bile Acid Profile and Intestinal Microbiota in Patients With Chronic Radiation Enteritis. J Dig Dis. 2026 Jan 28. doi: 10.1111/1751-2980.70029. Online ahead of print.

  PMID: 41605669 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples will be stored in liquid nitrogen.

Study Officials

• Yongquan Shi, PhD

  Xijing Hosipital of Digestive Disease

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 14, 2023
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 1, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

CN (1)