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)

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Disease (IBD); Metabolic Dysfunction Associated Fatty Liver Disease

• Study Type: Observational
• Enrollment (Estimated): 337

Contacts and Locations

• Study Contact: Name: Lan Zhong, MD; Phone Number: 8613162099450; Email: lanzhong@tongji.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai East Hospital
    • Contact: Lan Zhong; Phone Number: 8613162099450; Email: lanzhong@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
IBD with MASLD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Follow-up for 54 weeks

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Dongfang Hospital Affiliated to Tongji University; Shanghai Pudong New Area Health Commission

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 20, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: 2024-PWDL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No