Impact of Direct-acting Antiviral Drugs on The Patterns of Gut Microbiota in Patients With HCV Re… (NCT06829966) | Clinical Trial Compass
CompletedNot Applicable
Impact of Direct-acting Antiviral Drugs on The Patterns of Gut Microbiota in Patients With HCV Related Chronic Liver Diseases
Egypt30 participantsStarted 2022-05-13
Plain-language summary
The recent introduction of direct-acting antiviral (DAA) therapy has dramatically changed the rates of cure of HCV infection even in difficult to treat subjects and in those with severe comorbidities . A growing number of studies have also demonstrated an improvement in liver stiffness, which is a surrogate marker of liver fibrosis, after HCV eradication. This may have a beneficial impact on the gut liver axis in these patients and may further contribute to slowing down the progression of the disease, potentially influencing the future occurrence of complications. The gut microbiota alpha diversity in cirrhotic patients, which was lower than that in healthy subjects, was significantly improved by the cure of HCV infection and a shift in the overall gut microbiota composition was observed compared to baseline. The abundance of potentially pathogenic bacteria (Enterobacteriaceae, Enterococcus, and Staphylococcus) was decreased after treatment.
Aim of study:
1-To determine the changes in gut microbiota in patients with HCV infections with / without liver cirrhosis.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: non-cirrhotic chronically infected patients with hepatitis C virus (group I), patients who are successfully treated from HCV after receiving 12 weeks of DAAs (Sofosbuvir, Daclatasvir) who achieved SVR (group II), and patients who relapsed after 12 weeks of DAAs(Sofosbuvir/Velpatasvir/Voxilaprevir) (group III). healthy control subjects who were matched for age and sex (group VI) were enrolled after obtaining their informed consent. - Exclusion Criteria:Patients receiving antibiotic treatment, probiotics, or any other medical treatment influencing intestinal microbiota 1 month before the start of the study as well as patients with any other viral infection as HBV, and HIV were excluded.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Describe the composition and structure of the gut microbiota of patients with chronic HCV without cirrhosis (Non-treated, relapsed, and those who achieved SVR) in comparison to their matching healthy controls