Gallstones and Risk of Inflammatory Bowel Disease

N/ACompletedNCT05882006

Hepatopancreatobiliary Surgery Institute of Gansu Province5,035 enrolled

Overview

The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease.

Crohn's disease and ulcerative colitis , collectively known as inflammatory bowel diseases , have increased substantially over the past few decades affecting nearly 6.8 million individuals worldwide. The etiology of IBD remains obscure, possibly involving a complex interaction between the genetic, environmental or microbial factors and the immune responses. Gallstone disease is one of the most common and costly gastroenterological disorders, with a prevalence of 10-20% in Europe and America. Considering that gallstones and IBD also share specific risk factors, such as obesity, inappropriate diet and metabolic hormone levels, and have the pathophysiologic linkage, such as changes in gut microbiota composition and bile acid profile, the investigators propose that the occurrence of gallstones may predict the subsequence risk of IBD. However, investigations concerning the association is lacking.

Study Type

OBSERVATIONAL

Enrollment

5,035

Conditions

Inflammatory Bowel Diseases

Interventions

gallstonesOTHER

fellow up if the patients have gallstones

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 90 years old * IBD established by standard criteria, either Crohn's disease or ulcerative colitis Exclusion Criteria: * Pregnant or nursing woman; * Prior abdominal surgery related to IBD, such as subtotal or total colectomy; * HIV infection or any congenital immunodeficiency at the time of inclusion; * Post organ transplant patients; * Patients suffering from cancer currently or in the past; * Patients suffering from significant cardiovascular disease; * Patients suffering from significant respiratory diseases; * Patients suffering from any other chronic severe diseases.

Locations (4)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Wuwei Tumor Hospital

Wuwei, Gansu, China

The Seventh Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

The prevalence of gallstone disease among patients with or without IBD

We assess the prevalence as the number of gallstone diseases divided by the number of IBD patients or non-IBD patients. Gallstone disease was diagnosed as presence of gallstones, cholecystectomy, choledocholithotomy and Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

Time frame: 10 years

The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease

The odds ratio is a ratio of two sets of odds: the odds in case group (gallstone diseases with IBD divided by non-gallstone disease with IBD) versus the odds in control group (gallstone diseases without IBD divided by non-gallstone disease without IBD). Finally, we can calculate the odds ratio by dividing the ratio of the case group by the ratio of the control group.

Time frame: 10 years

Data from ClinicalTrials.gov

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