Influence of Gut Microbiome in Gallstone Disease

NCT05732480 | Recruiting

• 1 other identifier: 2022/SURG/01
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gall Stone; Gall Stones, Common Bile Duct; Pancreatitis; Acute Cholecystitis

Outcome Measures

Primary Outcomes (1)

• Bacterial DNA profile

  The diversity of species present in the stool of participants

  through study completion, up to 3 years from cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• East Kent Hospitals University NHS Foundation Trust: lead

Study Sites (1)

EKHUFT

Ashford, Kent, TN24 0LZ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We are collecting stool samples to analyse bacterial DNA however patient DNA will also be present in these samples. Samples will be destroyed at the end of the study.

MeSH Terms

Conditions

Gallstones; Pancreatitis; Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Cholecystitis

Central Study Contacts

Charlotte Burford

CONTACT

+44 1227 766877; charlotte.burford1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 17, 2023
• Study Start: May 30, 2023
• Primary Completion: November 13, 2025
• Study Completion (Estimated): November 13, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

GB (1)