Clinical trial NCT06694883: Critical State of "Remission-Recurrence" of Ulcerative Colitis
Official title: Research on the Biological Basis of "Disease-Syndrome-Formula" in the Critical State of "Remission-Recurrence" of Ulcerative Colitis (Joint Application A)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Visited the Digestive Department Outpatient Department of Beijing Hospital of Traditional Chinese Medicine

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The recurrence rate of patients
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Dongcheng
country: China
facility: Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Shengsheng Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.