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

Sponsor
Xijing Hospital of Digestive Diseases (Other)
Overall Status
Recruiting
CT.gov ID
NCT05728060
Collaborator
(none)
60
Enrollment
1
Location
15
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
    Actual Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

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

    1. Correlation between fecal bile acid profile and intestinal microbiota in different groups. [7 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts 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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xijing Hosipital of Digestive Disease Xi'an Shaanxi China 710032

    Sponsors and Collaborators

    • Xijing Hospital of Digestive Diseases

    Investigators

    • Study Director: Yongquan Shi, PhD, Xijing Hosipital of Digestive Disease

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
    ClinicalTrials.gov Identifier:
    NCT05728060
    Other Study ID Numbers:
    • KY20222208-F-1
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yongquan Shi, Principal Investigator, Clinical Professor, Xijing Hospital of Digestive Diseases
    Radiation Enteritis
    Bile Acid
    Gut Microbiota
    Additional relevant MeSH terms:
    Enteritis

    Study Results

    No Results Posted as of Feb 21, 2023