NCT06939569Recruiting
An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Source: ClinicalTrials.gov · Last updated 23 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, are currently of unknown etiology and incurable. In recent years, the incidence of IBD has increased dramatically in China, and it will become a common disease of digestive system in China. Mesenteric adipose tissue hyperplasia indicates disease activity in IBD patients, and abnormal lipid metabolism plays an important role in the pathogenesis of IBD. In addition to intestinal symptoms, nonalcoholic fatty liver disease (NAFLD), also known as metabolic dysfunction associated fatty liver disease (MASLD), has become the most common extraintinal manifestation in IBD patients. What are the similarities and differences between IBD patients with and without MASLD? Does the occurrence and severity of MASLD affect the clinical efficacy of IBD and increase the adverse outcome of IBD? There are no relevant studies to date. We have previously completed the construction of a cohort of 290 IBD patients using the IBD patient database and biobank of Dongfang Hospital, based on which we completed a cohort study on the effect of small intestinal bacterial overgrowth on IBD disease activity. Based on this cohort, multi-center cooperation was carried out to establish an IBD research cohort by collecting basic clinical information and biological samples such as peripheral blood and intestinal mucosa. The clinical characteristics of IBD patients with MASLD were analyzed. logistic regression, COX regression, Kaplan-Meier survival curve and other methods were used. To investigate the effect of MASLD on the clinical efficacy and prognosis of inflammatory bowel disease (IBD). This project will provide efficient, full and reliable research-grade data with Chinese characteristics for IBD clinical research, and improve the level of regional diagnosis and treatment.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 337 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Shanghai East Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06939569
What you commit to
- Study type: Observational
- Planned participants: 337
- From 1 May 2025 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;
- 5.Subjects with severe heart, lung, kidney and other organ diseases or cancer, and expected survival time less than 6 months.
Other
- Subjects with incomplete clinical data;
- Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;
Who the study is looking for
- Subjects aged over 18 years (including borderline values), of either sex.
- Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD;
- Subjects able to cooperate with follow-up, participate in this study and sign the informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.