Clinical trial NCT05882006: Gallstones and Risk of Inflammatory Bowel Disease
Official title: A Multicenter Case-control Study of the Association Between the Presence of Gallstone Disease and Risk of Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Gallstone
Crohn's disease
ulcerative colitis
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 5035
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IBD patients

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The prevalence of gallstone disease among patients with or without IBD
timeFrame: 10 years
measure: The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Wuwei
country: China
facility: Wuwei Tumor Hospital
state: Gansu
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, M.D.
role: STUDY_CHAIR
References:
citation: 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.
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.