Influence of Gut Microbiome in Gallstone disease

• Research type

  Research Study

• Full title

  Understanding changes in the gut microbiome in patients with Gallstone Disease and its impact on patient outcomes

• IRAS ID

  311862

• Contact name

  Ankur Shah

• Contact email

  ankur.shah1@nhs.net

• Sponsor organisation

  East Kent University Hospitals NHS Foundation Trust

• Duration of Study in the UK

  3 years, 5 months, 5 days

• Research summary

  Gallstone disease affects around 10-15% of people and over 65,000 people undergo a cholecystectomy (gallbladder removal) every year in the UK. The waiting time for a cholecystectomy can be over a year with some patients experiencing complications within this time. In addition, some patients may experience complications after surgery. Research has shown an association between the gut microbiome (the bacterial population residing in the digestive tract) and other abdominal diseases but less is known about its role in gallstone disease including the association with development of complications and the effects of cholecystectomy.
  
  The purpose of this study is to determine if there are differences in the gut microbiome of patients who experience complications related to gallstones compared to those patients with gallstones who do not experience any problems. Similarly, we would like to see if there are any differences in the gut microbiomes’ of patients before and after the gall bladder surgery. This would be a pilot study to determine if a larger scale study would be feasible and if there is potential to manipulate the gut microbiome to improve patient outcomes.

  Participants who consent to study participation will be asked to provide stool samples at the following time points:
  at time of diagnosis
  at 6 months following diagnosis
  before their elective surgery (if applicable)
  if they have any readmissions to hospital with complications of gallstone disease during the study period
  immediately after and at 6 months following cholecystectomy
  Patients will be contacted for a final sample at 3 years after enrollment or following cholecystectomy if applicable

  Stool sample collection can be done either at home or in hospital.
  Stool samples will be analysed for the bacterial population and the stool metabolome and collated with clinical data including blood test results and any relevant imaging investigations. Interim data analysis will be completed at 18 months.

• REC name

  Wales REC 3

• REC reference

  22/WA/0250

• Date of REC Opinion

  25 Oct 2022

• REC opinion

  Further Information Favourable Opinion