Inflammatory Bowel DiseasesNCT05882006
Gallstones and Risk of Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 4 sites in China.
Trial summary
The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- gallstones
- How many people
- 5,035 participants
- Where
- 4 sitesChina
- Study dates
- 21 May 2023to 16 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD patients
Who may be able to join
- Age between 18 and 90 years old
- IBD established by standard criteria, either Crohn's disease or ulcerative colitis
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
China4 sites
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
Lanzhou University Second Hospital
Lanzhou, Gansu, 730000
The Seventh Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518107
Wuwei Tumor Hospital
Wuwei, Gansu, 733099
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- gallstones
- Keywords
- Gallstone, Crohn's disease, ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Gallstones, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallstonesOther
fellow up if the patients have gallstones
| Study group | Role | What they receive |
|---|---|---|
| cases | IBD patients (including Crohn's disease and Ulcerative colitis) Receives: Other: 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 Receives: Other: gallstones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start21 May 2023
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D., Study chair, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882006
- Sponsor's protocol ID
- IBD Risk of Gallstones
- Status last verified
- Nov 2024
- First submitted
- 21 May 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completed
Publications
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.
PubMed 31648971Lammert 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.
PubMed 27121416Mi N, Yang M, Wei L, Nie P, Zhan S, Nguyen LH, Smith FG, Acharjee A, Liu X, Huang J, Xia B, Yuan J, Meng W. Gallstone Disease Is Associated With an Increased Risk of Inflammatory Bowel Disease: Results From 3 Prospective Cohort Studies. Am J Gastroenterol. 2025 Jan 1;120(1):204-212. doi: 10.14309/ajg.0000000000003111. Epub 2024 Oct 4.
PubMed 39364876
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Case-control Study of the Association Between the Presence of Gallstone Disease and Risk of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05882006
- Acronym / sponsor ID
- IBD Risk of Gallstones
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Gallstone, Crohn's disease, ulcerative colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,035 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 21 May 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: gallstonesIBD patients (including Crohn's disease and Ulcerative colitis) |
| controls | – | Other: gallstonesAge, 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD patients
Key inclusion criteria (2 listed)
- Age between 18 and 90 years old
- IBD established by standard criteria, either Crohn's disease or ulcerative colitis
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gallstonesfellow up if the patients have gallstones | Other | cases, controls |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 31648971GBD 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.
- Background: PubMed 27121416Lammert 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.
- Derived from this study: PubMed 39364876Mi N, Yang M, Wei L, Nie P, Zhan S, Nguyen LH, Smith FG, Acharjee A, Liu X, Huang J, Xia B, Yuan J, Meng W. Gallstone Disease Is Associated With an Increased Risk of Inflammatory Bowel Disease: Results From 3 Prospective Cohort Studies. Am J Gastroenterol. 2025 Jan 1;120(1):204-212. doi: 10.14309/ajg.0000000000003111. Epub 2024 Oct 4.
- Individual participant dataSharing planned: Undecided. After completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbo Meng, M.D. study chair
Hepatopancreatobiliary Surgery Institute of Gansu Province
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of gallstone disease among patients with or without IBD (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882006, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.