Gallstones and Risk of Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882006
• Other study ID #: IBD Risk of Gallstones
• Status: Recruiting
• Start date: May 21, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D.
• Phone: 13919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• gallstones
fellow up if the patients have gallstones

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Seventh Affiliated Hospital, Sun Yat-Sen University	Shenzhen	Guangdong
China	Wuwei Tumor Hospital	Wuwei	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21. — View Citation

Lammert F, Gurusamy K, Ko CW, Miquel JF, Mendez-Sanchez N, Portincasa P, van Erpecum KJ, van Laarhoven CJ, Wang DQ. Gallstones. Nat Rev Dis Primers. 2016 Apr 28;2:16024. doi: 10.1038/nrdp.2016.24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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