Gallstones and Risk of Inflammatory Bowel Disease

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882006

Collaborator

(none)

5,000

Enrollment

Locations

7.4

Anticipated Duration (Months)

1250

Patients Per Site

169.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Other: gallstones

Detailed Description

Crohn's disease (CD) and ulcerative colitis (UC), collectively known as inflammatory bowel diseases (IBDs), have increased substantially over the past few decades affecting nearly 6.8 million individuals worldwide[1]. The etiology of IBD remains obscure, possibly involving a complex interaction between the genetic, environmental or microbial factors and the immune responses. Gallstone disease (GSD) is one of the most common and costly gastroenterological disorders, with a prevalence of 10-20% in Europe and America[2]. Considering that gallstones and IBD also share specific risk factors, such as obesity[2, 3], inappropriate diet[2, 4] and metabolic hormone levels[5, 6], and have the pathophysiologic linkage, such as changes in gut microbiota composition[5] and bile acid profile[7], we propose that the occurrence of gallstones may predict the subsequence risk of IBD. However, investigations concerning the association is lacking.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

May 21, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
cases IBD patients (including Crohn's disease and Ulcerative colitis)	Other: gallstones fellow up if the patients have gallstones
controls 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 fellow up if the patients have gallstones

Arm

Intervention/Treatment

cases

IBD patients (including Crohn's disease and Ulcerative colitis)

Other: gallstones

fellow up if the patients have gallstones

controls

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

fellow up if the patients have gallstones

Outcome Measures

Primary Outcome Measures

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).
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu	China	730000
2	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730000
3	Wuwei Tumor Hospital	Wuwei	Gansu	China	733099
4	The Seventh Affiliated Hospital, Sun Yat-Sen University	Shenzhen	Guangdong	China	518107