NCT06939569 An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
| NCT ID | NCT06939569 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai East Hospital |
| Condition | Inflammatory Bowel Disease (IBD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 337 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 337 participants in total. It began in 2025-05-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged over 18 years (including borderline values), of either sex. 2. Subjects consistented with the Chinese consensus on the diagnosis and treatment of IBD; 3. Subjects able to cooperate with follow-up, participate in this study and sign the informed consent. Exclusion Criteria: 1. Subjects with incomplete clinical data; 2. Subjects can not to cooperate with follow-up, and refuse to sign the informed consent; 3. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06939569 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease (IBD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06939569 currently recruiting?
Yes, NCT06939569 is actively recruiting participants. Contact the research team at lanzhong@tongji.edu.cn for enrollment information.
Where is the NCT06939569 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06939569 clinical trial?
NCT06939569 is sponsored by Shanghai East Hospital. The trial plans to enroll 337 participants.