Gallstones and Risk of Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Other: gallstones
- Registration Number
- NCT05882006
- Lead Sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Brief Summary
The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5035
- Age between 18 and 90 years old
- IBD established by standard criteria, either Crohn's disease or ulcerative colitis
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description cases gallstones IBD patients (including Crohn's disease and Ulcerative colitis) controls gallstones 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
- Primary Outcome Measures
Name Time Method The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease 10 years 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.
The prevalence of gallstone disease among patients with or without IBD 10 years 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- 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