Gallstones and Risk of Inflammatory Bowel Disease

July 19, 2023 updated by: Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province

A Multicenter Case-control Study of the Association Between the Presence of Gallstone Disease 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Hepatopancreatobiliary Surgery Institute of Gansu Province
        • Principal Investigator:
          • Wenbo Meng, MD,PhD
        • Contact:
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
      • Wuwei, Gansu, China, 733099
        • Recruiting
        • Wuwei Tumor Hospital
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518107
        • Recruiting
        • The Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

IBD patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Investigators

  • Study Chair: Wenbo Meng, M.D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBD Risk of Gallstones

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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