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Gallstones and Risk of Inflammatory Bowel Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05882006
Enrollment
5035
Registered
2023-05-31
Start date
2023-05-21
Completion date
2024-11-16
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases

Keywords

Gallstone, Crohn's disease, ulcerative colitis

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.

Interventions

OTHERgallstones

fellow up if the patients have gallstones

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of gallstone disease among patients with or without IBD10 yearsWe 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).
The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease10 yearsThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026