Ulcerative ColitisCSRRUCNCT06694883
Critical State of "Remission-Recurrence" of Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 19 Sep 2024to May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Visited the Digestive Department Outpatient Department of Beijing Hospital of Traditional Chinese Medicine
Who may be able to join
- Patients who meet the criteria based on the clinical characteristics of ulcerative colitis patients in the "remission recurrence" critical state, combined with clinical symptoms, are diagnosed with ulcerative colitis through imaging, endoscopy, laboratory, and histopathological examinations;
- Patients with comprehensive laboratory testing indicators.
Who cannot join
- Patients with incomplete case information records;
- Patients who have not completed serological tests;
- Complications including intestinal obstruction, intestinal perforation, toxic megacolon, and severe local stenosis;
- Diagnosed or suspected patients with coexisting uncertain colitis, infectious or ischemic colitis;
- Patients with coexisting local or systemic infections, any malignant diseases, or autoimmune diseases;
- Merge primary diseases such as respiratory, circulatory, neurological, endocrine, and hematological disorders;
- Individuals at risk of developing cancer;
- regnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Dongcheng, Beijing Municipality, 100010
Luqing Zhao, Doctor, +8601087906580, zhaoluqing@bjzhongyi.com
About this study
Official title: Research on the Biological Basis of "Disease-Syndrome-Formula" in the Critical State of "Remission-Recurrence" of Ulcerative Colitis (Joint Application A)
This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety self-assessment scale, depression self-assessment scale, etc., every month. Collect blood, urine, and stool samples from patients every month for examination. Follow up for each subject until their condition recurs.
- Conditions
- Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
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 |
|---|---|---|
| Ulcerative colitis in remission period | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of patients
The recurrence rate of 100 follow-up patients was counted at the end of the follow-up period
Measured: The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start19 Sep 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengsheng Zhang, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Shengsheng Zhang, Doctor, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694883
- Sponsor's protocol ID
- 82341235
- Acronym
- CSRRUC
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fukuda T, Naganuma M, Sugimoto S, Nanki K, Mizuno S, Mutaguchi M, Nakazato Y, Inoue N, Ogata H, Iwao Y, Kanai T. The risk factor of clinical relapse in ulcerative colitis patients with low dose 5-aminosalicylic acid as maintenance therapy: A report from the IBD registry. PLoS One. 2017 Nov 6;12(11):e0187737. doi: 10.1371/journal.pone.0187737. eCollection 2017.
PubMed 29108025Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial. J Clin Gastroenterol. 2016 Apr;50(4):318-25. doi: 10.1097/MCG.0000000000000414.
PubMed 26368296Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis: an update. Clin Med (Lond). 2021 Mar;21(2):135-139. doi: 10.7861/clinmed.2021-0080.
PubMed 33762374
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Biological Basis of "Disease-Syndrome-Formula" in the Critical State of "Remission-Recurrence" of Ulcerative Colitis (Joint Application A)
- ClinicalTrials.gov ID
- NCT06694883
- Acronym / sponsor ID
- CSRRUC / 82341235
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 19 Nov 2024 (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.
This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety self-assessment scale, depression self-assessment scale, etc., every month. Collect blood, urine, and stool samples from patients every month for examination. Follow up for each subject until their condition recurs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis in remission period | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Visited the Digestive Department Outpatient Department of Beijing Hospital of Traditional Chinese Medicine
Key inclusion criteria (2 listed)
- Patients who meet the criteria based on the clinical characteristics of ulcerative colitis patients in the "remission recurrence" critical state, combined with clinical symptoms, are diagnosed with ulcerative colitis through imaging, endoscopy, laboratory, and histopathological examinations;
- Patients with comprehensive laboratory testing indicators.
Key exclusion criteria (8 listed)
- Patients with incomplete case information records;
- Patients who have not completed serological tests;
- Complications including intestinal obstruction, intestinal perforation, toxic megacolon, and severe local stenosis;
- Diagnosed or suspected patients with coexisting uncertain colitis, infectious or ischemic colitis;
- Patients with coexisting local or systemic infections, any malignant diseases, or autoimmune diseases;
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
The recurrence rate of patients
Time frame: The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process
The recurrence rate of 100 follow-up patients was counted at the end of the follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Results publication: PubMed 29108025Fukuda T, Naganuma M, Sugimoto S, Nanki K, Mizuno S, Mutaguchi M, Nakazato Y, Inoue N, Ogata H, Iwao Y, Kanai T. The risk factor of clinical relapse in ulcerative colitis patients with low dose 5-aminosalicylic acid as maintenance therapy: A report from the IBD registry. PLoS One. 2017 Nov 6;12(11):e0187737. doi: 10.1371/journal.pone.0187737. eCollection 2017.
- Results publication: PubMed 26368296Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Barrett AC, Bortey E, Paterson C, Forbes WP, Lichtenstein GR. Once-daily Mesalamine Formulation for Maintenance of Remission in Ulcerative Colitis: A Randomized, Placebo-controlled Clinical Trial. J Clin Gastroenterol. 2016 Apr;50(4):318-25. doi: 10.1097/MCG.0000000000000414.
- Results publication: PubMed 33762374Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis: an update. Clin Med (Lond). 2021 Mar;21(2):135-139. doi: 10.7861/clinmed.2021-0080.
- Individual participant dataSharing planned: No
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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.
Shengsheng Zhang, Doctor principal investigator
Beijing Hospital of Traditional Chinese Medicine
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 Ulcerative Colitis, run by Beijing Hospital of Traditional Chinese Medicine 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 2 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: status not confirmed, as of the sponsor's last update on 19 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danyan Li, Doctor (15811263607, danyan20121027@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recurrence rate of patients (time frame: The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process). 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 NCT06694883, which also lists 3 linked publications.
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 19 Nov 2024.