Actively Recruiting
A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Led by Shanghai East Hospital · Updated on 2025-04-23
337
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai East Hospital
Lead Sponsor
S
Shanghai Pudong New Area Health Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, which are incurable and increasing in incidence in China. This study focuses on the relationship between IBD and nonalcoholic fatty liver disease (NAFLD), also called metabolic dysfunction associated fatty liver disease (MASLD), which is a common extraintestinal condition in IBD patients. The research aims to understand how MASLD affects IBD symptoms, treatment outcomes, and prognosis using data from a large patient cohort. This is an observational, multicenter cohort study that collects clinical information and biological samples such as peripheral blood and intestinal mucosa from IBD patients with and without MASLD. The study will analyze clinical characteristics and use statistical methods like logistic regression, COX regression, and Kaplan-Meier survival curves to investigate disease activity and prognosis. No drugs or interventions are administered as part of the study. Participants will be followed for 54 weeks to assess clinical or endoscopic remission as the main outcome. Researchers will monitor disease progression and treatment effects through regular follow-up visits. The study will provide valuable data for improving diagnosis and treatment of IBD patients with MASLD in the region. Total participation time includes the follow-up period and cooperation with clinical evaluations and sample collection.
CONDITIONS
Brief Title
An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged over 18 years (including borderline values), of either sex.
- Diagnosed with inflammatory bowel disease according to Chinese consensus guidelines.
- Able to cooperate with follow-up visits and willing to sign informed consent.
You will not qualify if you...
- Incomplete clinical data.
- Unable or unwilling to cooperate with follow-up or sign informed consent.
- Unable to complete relevant examinations.
- Pregnant women.
- Severe heart, lung, kidney, or other organ diseases or cancer with expected survival less than 6 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 54 weeks
Participants with inflammatory bowel disease and non-alcoholic fatty liver disease are observed to assess clinical and endoscopic remission over time.
Regular follow-up visits during the 54 weeks
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
L
Lan Zhong, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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