Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05728060
Enrollment
60
Registered
2023-02-14
Start date
2022-12-01
Completion date
2024-03-01
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Enteritis

Keywords

Radiation Enteritis, Bile Acid, Gut Microbiota

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.

Interventions

None listed

Sponsors

Xijing Hospital of Digestive Diseases
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Correlation between fecal bile acid profile and chronic radiation enteritis7 monthsPatients' 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.

Secondary

MeasureTime frameDescription
Correlation between fecal bile acid profile and intestinal microbiota in different groups.7 monthsInvestigators explore the cross-talk between fecal bile acid and gut microbiota according to the results of 16s rRNA sequencing.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026