Radiation EnteritisNCT05728060
Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
An observational study of Radiation Enteritis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Radiation Enteritis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients are from Xijing Hospital.
Who may be able to join
- . 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.
Who cannot join
- . 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;
Trial locations and contacts
1 site in 1 country.
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (1)
Correlation between fecal bile acid profile and intestinal microbiota in different groups.
Investigators explore the cross-talk between fecal bile acid and gut microbiota according to the results of 16s rRNA sequencing.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Dec 2022
- Primary completion1 Oct 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation EnteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Yongquan Shi, PhD, Study director, Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728060
- Sponsor's protocol ID
- KY20222208-F-1
- Status last verified
- Jul 2025
- First submitted
- 4 Feb 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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-Feb;27(1-2):40-49. doi: 10.1111/1751-2980.70029. Epub 2026 Jan 28.
PubMed 41605669
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
- ClinicalTrials.gov ID
- NCT05728060
- Acronym / sponsor ID
- KY20222208-F-1
- Conditions
- Radiation Enteritis
- Keywords
- Radiation Enteritis, Bile Acid, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients are from Xijing Hospital.
Key inclusion criteria (4 listed)
- . 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.
Key exclusion criteria (8 listed)
- . 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between fecal bile acid profile and intestinal microbiota in different groups.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 41605669Shen 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-Feb;27(1-2):40-49. doi: 10.1111/1751-2980.70029. Epub 2026 Jan 28.
Related trials for Radiation Enteritis
RecruitingObservational study
Association Between Clinical Classification and Prognosis in Chronic Radiation Enteropathy
Radiotherapy, Radiation Proctitis
Not yet recruitingObservational study
Plasma GLP-2 Dynamics and Acute Radiation Enteritis After Abdominopelvic Radiotherapy
Radiation Enteritis
Not yet recruitingPhase 2
Improvement Effect of Dexamethasone Enema for Acute Radiation-induced Rectal Injury
Acute Radiation Enteritis
RecruitingPhase 2
Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.
Radiation Enteritis
Active, not recruitingPhase 1/2
CMTS0515-auWMT for Radiation Enteritis
Radiation Enteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongquan Shi, PhD study director
Xijing Hosipital of Digestive Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Enteritis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between fecal bile acid profile and chronic radiation enteritis (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05728060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.