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Completed

NCT Number: NCT05728060

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

;

  • . 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;

Treatment and study plan

Primary outcomes

  1. Correlation between fecal bile acid profile and chronic radiation enteritis

    Time frame: 7 months

    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.

Secondary outcomes

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

    Time frame: 7 months

    Investigators explore the cross-talk between fecal bile acid and gut microbiota according to the results of 16s rRNA sequencing.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 14, 2023
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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