P5794 - Adjunctive Fecal Microbiota Transplantation Lowers Recurrence of Overt Hepatic Encephalopathy Without Added Harm: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Ashesh Das, MBBS¹, Urvashi Bharia, ², Jana Al Jnainati, MD³, Amrita Naskar, ⁴, Jasmeet Singh, MBBS⁵, Gautami Bradoo, MBBS⁶, Jainishkumar S. Patel, MBBS⁷, Shreya Muddana, ⁸, Yash Balubhai. Nasit, MBBS⁹, Aamuktha Marepalli, ¹⁰
1KPC Medical College and Hospital , Kolkata, India, Kolkata, West Bengal, India; 2Lokmanya Tilak Municipal Medical College and General Hospital, Mumbai, Navi Mumbai, Maharashtra, India; 3University of Milan–Bicocca: Universita degli Studi di Milano-Bicocca, Bergamo, Lombardia, Italy; 4Institute of Post-Graduate Medical Education & Research And SSKM Hospital, Kolkata, West Bengal, India; 5University college of medical sciences and GTB hospital, New Delhi, Delhi, India; 6NAMO medical education and research institute and NAMO hospital, Silvassa, India, Silvassa, Dadra and Nagar Haveli, India; 7General Hospital, Chhotaudepur, Gujarat, India, Bodeli, Gujarat, India; 8Mamata Academy of Medical Sciences and Hospital , Hyderabad, India, Hyderabad, Telangana, India; 9Government Medical College and Hospital, Surat, Surat, Gujarat, India; 10Sri Venkateswara Medical College-Sri Padmavathi college for women, Tirupati, Andhra Pradesh, India

Introduction: Hepatic encephalopathy (HE) recurs in approximately 40 % of cirrhotic patients despite taking lactulose and rifaximin, driven partly by persistent gut dysbiosis. Faecal microbiota transplantation (FMT) rapidly re-establishes eubiotic flora and may therefore avert relapse. We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) assessing adjunctive FMT to prevent recurrent overt HE.

Methods: A systematic search of PubMed, Embase, Scopus, and Cochrane Library identified Randomized Controlled Trials (RCTs) analyzing adjunctive faecal microbiota transplantation (FMT) for preventing recurrent overt hepatic encephalopathy in cirrhosis upto May 2025. Data were analysed using RevMan 4.2.1. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated using Mantel-Haenszel methods. Random- or fixed-effects models were applied based on heterogeneity (Higgins’ I²). Statistical significance was set at p < 0.05. Risk of bias was assessed using RoB 2.0.

Results: Three RCTs (Bajaj 2017, 2019 and 2025; 35 FMT vs 35 standard-of-care [SOC] participants) met eligibility. Adjunctive FMT conferred a clinically meaningful and statistically significant reduction in recurrent overt HE within 180 days (risk ratio [RR] 0.23, 95 % CI 0.08–0.66; I² = 0 %, P = 0.006). Numerically fewer hospital readmissions (RR 0.42, 95 % CI 0.17–1.05; I² = 0 %, P = 0.06) and composite adverse events (RR 0.41, 95 % CI 0.13–1.36; I² = 60 %, P = 0.15) were observed, but these did not reach conventional significance. All-cause mortality was low and comparable between groups (RR 0.60, 95 % CI 0.08–4.24; I² = 0 %, P = 0.61). Importantly, no FMT-related serious adverse events were reported across trials, regardless of delivery route or dosing schedule.

Discussion: Collectively, the current published literature shows that adjunctive FMT provides a clinically meaningful, safe means of curbing early HE recurrence, underscoring the therapeutic value of microbiome modulation in cirrhosis. The consistent direction of benefit across differing delivery protocols strengthens biological plausibility, yet the small, single-centre nature of available trials limits certainty for secondary endpoints. Larger, multicentre studies powered for patient-centred outcomes, mechanistic biomarkers and cost-effectiveness are needed to refine donor selection, optimise dosing frequency and confirm long-term sustainability before routine implementation.


Figure: Figure Showing Forest Plots Showing All Cause Mortality, Hospital Re-Admission, Recurrent Overt HE over 180days & Adverse Events


Figure: Prisma Flowchart

Disclosures:
Ashesh Das indicated no relevant financial relationships.
Urvashi Bharia indicated no relevant financial relationships.
Jana Al Jnainati indicated no relevant financial relationships.
Amrita Naskar indicated no relevant financial relationships.
Jasmeet Singh indicated no relevant financial relationships.
Gautami Bradoo indicated no relevant financial relationships.
Jainishkumar Patel indicated no relevant financial relationships.
Shreya Muddana indicated no relevant financial relationships.
Yash Nasit indicated no relevant financial relationships.
Aamuktha Marepalli indicated no relevant financial relationships.

Ashesh Das, MBBS¹, Urvashi Bharia, ², Jana Al Jnainati, MD³, Amrita Naskar, ⁴, Jasmeet Singh, MBBS⁵, Gautami Bradoo, MBBS⁶, Jainishkumar S. Patel, MBBS⁷, Shreya Muddana, ⁸, Yash Balubhai. Nasit, MBBS⁹, Aamuktha Marepalli, ¹⁰. P5794 - Adjunctive Fecal Microbiota Transplantation Lowers Recurrence of Overt Hepatic Encephalopathy Without Added Harm: A Systematic Review and Meta-analysis of Randomized Controlled Trials, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.