Critical State of "Remission-Recurrence" of Ulcerative Colitis

NCT ID: NCT06694883

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-19

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative colitis in remission period

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Shengsheng Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengsheng Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of Traditional Chinese Medicine

Locations

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Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Dongcheng, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Danyan Li, Doctor

Role: CONTACT

15811263607

Yun Ma, Master

Role: CONTACT

13681009659

Facility Contacts

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Luqing Zhao, Doctor

Role: primary

+8601087906580

References

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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.

Reference Type BACKGROUND
PMID: 29108025 (View on PubMed)

Gordon 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.

Reference Type BACKGROUND
PMID: 26368296 (View on PubMed)

Segal JP, LeBlanc JF, Hart AL. Ulcerative colitis: an update. Clin Med (Lond). 2021 Mar;21(2):135-139. doi: 10.7861/clinmed.2021-0080.

Reference Type BACKGROUND
PMID: 33762374 (View on PubMed)

Other Identifiers

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82341235

Identifier Type: -

Identifier Source: org_study_id

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