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Gallstones and Risk of Inflammatory Bowel Disease

H

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Completed

Conditions

Inflammatory Bowel Diseases

Treatments

Other: gallstones

Study type

Observational

Funder types

Other

Identifiers

NCT05882006
IBD Risk of Gallstones

Details and patient eligibility

About

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

Full 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.

Enrollment

5,035 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

5,035 participants in 2 patient groups

cases
Description:
IBD patients (including Crohn's disease and Ulcerative colitis)
Treatment:
Other: gallstones
controls
Description:
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
Treatment:
Other: gallstones

Trial contacts and locations

4

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Central trial contact

Wenbo Meng, M.D.; Ningning Mi, M.D.

Data sourced from clinicaltrials.gov

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