Chronic Liver Disease and Cirrhosis Clinical Trial
Official title:
Assessment of Invasive Fungal Infections as a Result of Fungal Dysbiosis in Patients With Severe Alcohol-associated Hepatitis
Chronic alcohol consumption is associated with intestinal bacterial dysbiosis, yet little is known about the role of intestinal fungi, or mycobiota in liver disease. Although the intestinal microbiome contains bacteria, fungi, and viruses, research in the field of liver disease has almost exclusively focused on the interaction between the host and gut bacteria. The fungal microbiota is an integral part of the gastrointestinal micro-ecosystem with up to 106 microorganisms per gram of faeces. Numerous interactions between fungi and bacteria and the complex immune response to gastrointestinal commensal or pathogenic fungi have been demonstrated in prior studies. Alcohol-dependent patients display a reduced intestinal fungal diversity and Candida overgrowth. Compared with healthy individuals and patients with non-alcohol-related cirrhosis, alcoholic cirrhosis patients also demonstrate systemic exposure and immune response to mycobiota. Thus, chronic alcohol consumption is associated with an altered mycobiota and translocation of fungal products. Manipulating the intestinal mycobiome might be an effective strategy for attenuating alcohol-related liver disease especially alcoholic hepatitis. In this study, we will attempt to find out the natural fungal mycobiome in Severe alcoholic hepatitis when compared with apparently healthy asymptomatic controls from their family. This will allow us to therapeutically modify the unbalanced gut microbiota and improve patient outcomes. Secondly, it will provide further insight as to why alcohol-associated hepatitis patients are particularly susceptible to fungal infections. In the age of frequent antibacterial drug therapy, the role of commensal and pathogenic fungi in the human gut has gained paramount importance.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Severe Alcoholic Hepatitis - Aged between 18 Years to 70 Years - Either gender - Study will also include age matched healthy controls from the patient's family Exclusion Criteria: 1. Inability to obtain informed consent from patient or relatives. 2. Severe cardiopulmonary disease 3. Pregnancy 4. HIV infection 5. Recent abdominal surgery (with in last 6 months) 6. Patient on immunosuppressive drugs 7. Malignancies including Hepatocellular carcinoma 8. Gastrointestinal (GI bleed) in the last 4 weeks 9. Oral antibiotics or antifungals taken in last 2 weeks. |
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical Education and Research | Chandigarh | Choose Any State/Province |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | Patients who survive till Day 28 and Day 90 | at Day 28 and Day 90 | |
Secondary | Non-elective hospital admissions | Number of hospital admissions will be documented | 90 Days | |
Secondary | Clinical and biochemical parameters will be compared at 0 and 90 days | Change in biochemical parameters including liver function tests, renal function tests, ammonia etc. | 90 days | |
Secondary | Clinical events like decompensation in the form of new onset ascites, variceal bleed, renal dysfunction, hepatic encephalopathy, infections | Number of decompensation events [ascites, variceal bleed, renal dysfunction, hepatic encephalopathy, infections] | 90 days |
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