Critical State of "Remission-Recurrence" of Ulcerative Colitis

NCT06694883 | Recruiting

• 1 other identifier: 82341235
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of patients

  The recurrence rate of 100 follow-up patients was counted at the end of the follow-up period

  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

Study Arms (1)

Ulcerative colitis in remission period

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Visited the Digestive Department Outpatient Department of Beijing Hospital of Traditional Chinese Medicine

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Dongcheng, Beijing Municipality, 100010, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 29108025 BACKGROUND

• 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.

  PMID: 26368296 BACKGROUND

• 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.

  PMID: 33762374 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood,urine,stool

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Shengsheng Zhang, Doctor

  Beijing Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danyan Li, Doctor

CONTACT

15811263607; danyan20121027@163.com

Yun Ma, Master

CONTACT

13681009659; mayun331@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 19, 2024
• Study Start: September 19, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)