Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05728060
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2023-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fecal samples will be stored in liquid nitrogen.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2023-02-04', 'studyFirstSubmitQcDate': '2023-02-04', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between fecal bile acid profile and chronic radiation enteritis', 'timeFrame': '7 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Correlation between fecal bile acid profile and intestinal microbiota in different groups.', 'timeFrame': '7 months', 'description': 'Investigators explore the cross-talk between fecal bile acid and gut microbiota according to the results of 16s rRNA sequencing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation Enteritis', 'Bile Acid', 'Gut Microbiota'], 'conditions': ['Radiation Enteritis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients are from Xijing Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. . non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy;\n2. . Patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent;\n3. . able to receive follow-up examinations, follow-up examinations, and specimen retention on time;\n4. . 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.\n\nExclusion Criteria;\n\n1. . Presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc;\n2. . Patients who have previously undergone cholecystectomy or partial resection of the intestine;\n3. . 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;\n4. . Recent use of drugs that affect gastrointestinal motility;\n5. . 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;\n6. . Patients with mental or legal disabilities;\n7. . 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;\n8. . Refuse to sign informed consent;'}, 'identificationModule': {'nctId': 'NCT05728060', 'briefTitle': 'Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital of Digestive Diseases'}, 'officialTitle': 'Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis', 'orgStudyIdInfo': {'id': 'KY20222208-F-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chronic radiation enteritis', 'description': 'Non-surgically treated cervical cancer patients develop chronic radiation enteritis after radiation therapy.'}, {'label': 'No chronic radiation enteritis after radiotherapy', 'description': 'Patients with non-surgical cervical cancer do not develop chronic radiation enteritis after radiation therapy.'}, {'label': 'Patients with cervical cancer', 'description': 'Patients with cervical cancer did not undergo any treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hosipital of Digestive Disease', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Yongquan Shi, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xijing Hosipital of Digestive Disease'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital of Digestive Diseases', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Yongquan Shi', 'investigatorAffiliation': 'Xijing Hospital of Digestive Diseases'}}}}