Assessment of Microorganisms and Host Response In Liver Diseases

NCT06291571 | Not Yet Recruiting

• 1 other identifier: 324543
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease.

Conditions

Gut Microbiome; Liver Diseases

Outcome Measures

Primary Outcomes (1)

• To identify the bacterial, fungal, and virological agents present in patients with liver disease as opposed to controls

  Microbiome analysis in liver patients and controls

  5 years

Secondary Outcomes (2)

• To assess the host immune response against specific microbes isolated from patients with liver disease and controls

  5 years

• To characterise the changes in the liver immune microenvironment by analysing liver biopsies from patients

  5 years

Study Arms (2)

Liver diseases

Patients with documented liver diseases

Control

Healthy volunteers without evidence of liver disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in clinics and wards in secondary care.

You may qualify if:

• Willing and able to provide informed consent
• Definitive diagnosis of specific liver disease utilising clinical, biochemical, and radiological tests
• Male or female aged between 18-70 years
• Able to understand written or verbal information in English

You may not qualify if:

• Pregnancy and breastfeeding
• Treatment with antibiotics in the last month
• Treatment with steroids or immunosuppressive drugs in the last month
• Regular consumption of over-the-counter prebiotics and probiotics from pharmacies or other retailers in the last month.
• Known gastrointestinal disease, including but not limited to ulcerative colitis, Crohn's disease, coeliac disease, microscopic colitis, diverticulitis, irritable bowel syndrome
• Patients diagnosed with cancer who are on chemotherapy, radiotherapy, or immunotherapy within the last 3 months

Sponsors & Collaborators

• University of Aberdeen: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Indrani Mukhopadhya

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indrani Mukhopadhya, PhD

CONTACT

07889761704; indrani.mukhopadhya@abdn.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 4, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 9, 2024

Record last verified: 2024-05