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Completed

NCT Number: NCT05882006

Gallstones and Risk of Inflammatory Bowel Disease

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gallstones

Other

fellow up if the patients have gallstones

Primary outcomes

  1. The prevalence of gallstone disease among patients with or without IBD

    Time frame: 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).

  2. The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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