Influence of Gut Microbiome in Gallstone Disease

February 22, 2024 updated by: East Kent Hospitals University NHS Foundation Trust

Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes

The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease.

The main question[s] it aims to answer are:

  • if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis)
  • if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes.

Participants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background:

Gallstone disease affects 10-15% of people in the United Kingdom (UK) and over 65,000 patients undergoing cholecystectomy each year, costing the National Health Service (NHS) over 110 million. There is increasing evidence suggesting differences in the gut microbiome of patients with gallstone disease compared to those without (including reduced diversity, decreased prevalence of beneficial and increased prevalence of pathogenic bacteria) but there are only a handful of small scale studies exploring the development of gallstone disease complications and patient outcomes to date.

Hypothesis and Objectives:

This pilot study aims to understand the profile of the gut microbiome in adult patients diagnosed with gallstone disease and its relationship with patient outcomes including:

Patients who develop complications of gallstone disease(including but not limited to biliary colic, cholangitis, cholecystitis, pancreatitis and gallstone ileus) following diagnosis and Patients who develop post-operative complications including short (hospital stay, wound healing etc) and intermediate (development of post-cholecystectomy diarrhoea) outcomes.

Design and Methods:

A prospective cohort design will be used to collect data from 75 adult patients presenting to East Kent University Hospitals NHS Foundation Trust Hospitals with newly diagnosed gallstone disease following confirmatory imaging investigations.

Data will be collected from electronic patient records including clinical history and diagnostic investigations, anthropometry, blood and imaging results (if taken as part of routine clinical care) for the initial presentation and subsequent readmissions/planned follow-up timepoints.

Stool samples will be collected from patients either during admission or at home at each timepoint. Samples will be returned by post to the research team where they will be stored and analysed. Patients will also be asked to provide a 3 day food diary card Patients will have a sample collected at time of diagnosis and then at 6 monthly intervals whilst awaiting cholecystectomy. A pre-operative sample will be required within 6 weeks of any surgical intervention. Following cholecystectomy an immediate post-operative sample (within the first week) will be collected as well as a sample at 6 months.

Clinical and Scientific Impact:

At least 20% of those patients awaiting cholecystectomy experience complications, costing the NHS over £25 million per year. Therefore, there is a huge need to understand mechanisms behind the development of complications and to reduce the symptom burden for patients as well as the financial burden for the NHS.

This study is the crucial first step in identifying differences in the gut microbiome between patients who experience complications (both pre and post-op) and those who do not. Once differences are discovered the next step will be to use the information discovered to determine interventions to reduce the development of these complications.

Study Type

Observational

Enrollment (Estimated)

75

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with gallstone disease presenting to an East Kent University Foundation Trust Hospital

Description

Inclusion Criteria:

  • All adults (age >18 years of age) patients diagnosed with gallstone disease following confirmatory imaging at an East Kent University Foundation Trust Hospital. Patients of any gender, ethnicity or socio-economic background are eligible as well as pregnant women. Patients undergoing both open and laparoscopic cholecystectomy will be included.

Exclusion Criteria:

  • Patients less than 18 years of age and patients who do not have capacity to consent to involvement in the study.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial DNA profile
Time Frame: through study completion, up to 3 years from cholecystectomy
The diversity of species present in the stool of participants
through study completion, up to 3 years from cholecystectomy

Collaborators and Investigators

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

Sponsor

East Kent Hospitals University NHS Foundation Trust

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 30, 2023

Primary Completion (Estimated)

November 13, 2025

Study Completion (Estimated)

November 13, 2026

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/SURG/01

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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