Bile acid and gut microbiota changes in people with hepatitis D starting bulevirtide
Official title: Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07429864 · Data updated 2026-11-12
This project will see if starting bulevirtide changes bile acids and gut bacteria in adults with chronic hepatitis D who are already on hepatitis B therapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | September 24, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07429864 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) of Caucasian ethnicity with chronic HDV infection and positive HDV RNA who have compensated liver disease (Child‑Pugh A), are on HBV therapy, and received their first 2 mg bulevirtide prescription within 30 days, with a normocaloric omnivorous diet and no antibiotics/probiotics/prebiotics in the prior month, are the intended participants.
✕Probably not a fit
People with decompensated cirrhosis (Child‑Pugh B/C), non‑HBV/HDV liver disease, recent antibiotic/probiotic use, pregnancy or breastfeeding, serious short‑term comorbidities, or inability to attend the Rome clinic are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with chronic hepatitis D who recently began bulevirtide are enrolled in an observational cohort and sampled for blood and stool. Researchers will profile circulating and fecal bile acids and sequence gut microbiota at baseline and during follow-up, excluding participants with recent antibiotic, probiotic, or prebiotic use. The study will correlate microbiome and bile acid shifts with HDV RNA, liver stiffness, and clinical status. Results aim to clarify how bulevirtide treatment interacts with bile acid metabolism and gut dysbiosis in patients with compensated liver disease.
Why it matters
Potential benefit: If successful, this work could identify bile acid or microbiome changes that help predict who benefits from bulevirtide or suggest targets to slow fibrosis progression.
How similar studies have gone: Bulevirtide has shown virologic response and reduced liver stiffness in prior trials and dysbiosis–bile acid links in cirrhosis are reported, but combining bulevirtide therapy with focused microbiome and bile acid monitoring is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A) * Positive HDV RNA within the 24 weeks prior to enrollment * Ongoing antiviral therapy for HBV at the time of enrollment * First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment * Caucasian ethnicity * Age ≥18 years * Normocaloric omnivorous diet * No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment * Signed informed consent Exclusion Criteria: * Decompensated liver cirrhosis (Child-Pugh Score B or C) * Patients without HBV-HDV-related infection/hepatitis/cirrhosis * Age ≤18 years * Pregnant or breastfeeding women * Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III/IV, COPD GOLD C-D) * Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition
Where it's running
-
Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD
Roma, Italy Recruiting
Study contacts
- Principal investigator: Francesca Romana Ponziani — Fondazione Policlinico A. Gemelli IRCCS
- Study coordinator: Francesca Romana Ponziani
- Email: francescaromana.ponziani@policlinicogemelli.it
- Phone: +390630159336
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.