Clinical trial NCT06939569: An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: A Bidirectional, Multicenter Cohort Study of Inflammatory Bowel Disease (IBD) Patients With Nonalcoholic Fatty Liver Disease (NAFLD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Disease (IBD)
Metabolic Dysfunction Associated Fatty Liver Disease
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong New Area Health Commission
name: Dongfang Hospital Affiliated to Tongji University
First posted: 2025-04-23
Enrollment: 337
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IBD by imaging, histology and/or endoscopy in IBD Diagnosis and Treatment Center of East Hospital, Pudong New Area, Shanghai

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.

Primary outcomes:
measure: Clinical remission or Endoscopic remission
timeFrame: Follow-up for 54 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
References: