A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis

Study Purpose

Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 14 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - sign informed consent before proceeding with any specific procedure.
  • - ages:14-75 - subjects were diagnosed with ulcerative colitis in written form.
(written diagnosis should include at least one histopathological change).
  • - mucosal healing or histological remission has been achieved after medical treatment.
1. histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors. 2. prospective cohort study
  • (3) definition of endoscopic mucosal healing: Baron score<=1 and Mayo score<=1 (4) definition of histological remission: Truelove/ Richards=1 and Geboes score<3.0 (5) sampling methods: the terminal ileum, the ascending colon, the transverse colon, the descending colon, the sigmoid colon, and the rectum, the six parts were randomly taken specimen (at least 2 tissues each).
  • - data integrity: the research data include: 1) enteroscopy; 2) laboratory examination indicators: blood routine, erythrocyte sedimentation rate, C reaction protein, liver function, renal function, fecal calprotectin, 3) serum concentration of infliximab, antibody to infliximab.
  • - subjects were treated with the following treatment Mesalazine, glucocorticoid, immunosuppressive agent (azathioprine or thalidomide), biologics (infliximab) 7.
subjects have the ability to answer the questionnaire

Exclusion Criteria:

  • - The diagnosis is unclear - Subjects with history of colectomy - Subjects with history of cancerogenesis - Subjects with severe liver disease, defined as child-pugh Grade B or Grade C - Subjects with severe renal disease, defined as Estimated glomerular filtration rate<30 - major cardiovascular events, such as stroke, myocardial infarction, or unstable angina, occurred within 3 months before enrollment.
  • - Subjects during pregnancy.
- alcohol or drug abuse - poor compliance 10 Planners and investors

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03698812

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Nanfang Hospital of Southern Medical University

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Xinying Wang
Principal Investigator Affiliation Nanfang Hospital of Southern Medical University

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Prospective Study, Ulcerative Colitis in Remission
Additional Details

Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Guangzhou, Guangdong, China

Status

Recruiting

Address

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, sunwingwxy@163.com

Site Contact

Xinying Wang, MD

sunwingwxy@163.com

13726754880

Nearest Location

Site Contact

Xinying Wang, MD

sunwingwxy@163.com

13726754880

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