Gallstones and Risk of Inflammatory Bowel Disease

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

Detailed Description
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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.

Official Title
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A Multicenter Case-control Study of the Association Between the Presence of Gallstone Disease and Risk of Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: gallstones


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>IBD patients (including Crohn's disease and Ulcerative colitis) | Other: gallstones<br>* fellow up if the patients have gallstones<br>|
| controls<br>Age, sex, and calendar-year matched controls sampled from non-IBD patients to be a round number of at least four times the number of cases | Other: gallstones<br>* fellow up if the patients have gallstones<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallstone, Crohn's disease, ulcerative colitis