An Observational Study of Inflammatory Bowel Disease (IBD) Patients With Non-alcoholic Fatty Liver Disease (NAFLD)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai East Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subjects with incomplete clinical data;

Subjects can not to cooperate with follow-up, and refuse to sign the informed consent;

Subjects can not to cooperate with the completion of relevant examinations; 4 Pregnant women;

Trial population

Patients diagnosed with IBD by imaging, histology and/or endoscopy in IBD Diagnosis and Treatment Center of East Hospital, Pudong New Area, Shanghai

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

337 Participants
are grouped into 1 trial group
Group A: IBD with MASLD

Trial outcomes

Primary outcomes

1

Clinical remission or Endoscopic remission

Clinical remission (CDAI≤150 in CD patients, Mayo≤2 in UC patients); Endoscopic remission (SES-CD in CD patients and UCEIS in UC patients with \> 50% improvement from baseline)

Time frame
Follow-up for 54 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Shanghai Pudong New Area Health Commission

Collaborator

Dongfang Hospital Affiliated to Tongji University

Collaborator