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                <title xml:lang="en">Rifaximin alters the intestinal microbiota of patients with severe cirrhosis and is associated with changes in disease severity: results from the multicenter ProPILA-Rifax study</title>
                <title xml:lang="fr">Le microbiote intestinal des patients atteints de cirrhose sévère est modifié par la rifaximine et est associé à des modifications de la sévérité de la maladie : résultats de l’étude multicentrique ProPILA-Rifax</title>
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                  <date type="start">2026-03-19</date>
                  <date type="end">2026-03-22</date>
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            <abstract xml:lang="en">
              <p>IntroductionGut dysbiosis is associated with the pathophysiology of cirrhosis and its complications. The mechanism of action of rifaximin (RFX) on the gut microbiota remains poorly understood. The aim of this study was to compare the effect of RFX versus placebo (PBO) on the gut microbiome and to identify microbial biomarkers associated with changes in disease severity, survival, and the incidence of spontaneous bacterial ascites infections (SBAI), using data from the randomized ProPILA-Rifax trial (NCT03069131).Patients and MethodsA total of 42 patients with severe cirrhosis were included and treated for 12 months with either RFX (n = 21) or PBO (n = 21). Stool samples were collected at day 1, month 3, month 6, month 12, and month 18. Microbial DNA was extracted, and libraries targeting the 16S rRNA gene were prepared and amplified for Illumina sequencing. Longitudinal gut microbiota profiles were characterized from amplicon data using a bioinformatics pipeline. Microbial richness, diversity, and composition were analyzed using linear mixed-effects models accounting for inter-patient random effects. Microbial biomarkers associated with Child-Pugh score were identified and used to stratify patients, from which survival curves and SBAI incidence analyses were generated.ResultsRFX treatment was associated with a decrease in gut microbiota richness compared with baseline throughout follow-up (P &amp;lt; 0.001), whereas no significant change was observed in the PBO group (P &amp;gt; 0.05). Microbiota diversity was significantly altered over time in the RFX arm (R² = 0.068; P = 0.001), whereas no significant change was observed in the PBO arm (R² = 0.038; P = 0.2). The relative abundance of several bacterial species, including Ruminococcus bromii and Roseburia inulinivorans, decreased specifically over time in the RFX arm. The relative abundance of several cirrhosis-associated species also decreased in the RFX arm, including Escherichia coli (P = 0.002) and Veillonella parvula (P = 0.005), whereas that of Blautia obeum (P = 0.03) and Fusicatenibacter saccharivorans (P = 0.004) increased. RFX treatment increased the proportion of rifampicin-resistant E. coli (P &amp;lt; 0.001), without any evidence of cross-resistance to ciprofloxacin or cefotaxime. In the mixed-effects model assessing the association between Child-Pugh score and bacterial species relative abundance, several taxa from the Firmicutes phylum, particularly Streptococcus spp. and Veillonella spp., were positively correlated with cirrhosis severity. Stratified Cox analyses showed that patients whose microbiota was enriched in E. coli or V. parvula had a higher risk of developing SBAI. Stratified survival analyses showed that patients whose microbiota was enriched in B. obeum and Intestinimonas timonensis had higher overall survival than those with lower abundance of these bacteria (respectively n = 17, P = 0.002; n = 13, P = 0.01).ConclusionRFX decreases the relative abundance of both cirrhosis-associated species and commensal species, without providing a beneficial effect on 12-month survival or SBAI incidence in this population of patients with severe cirrhosis. In this cohort, intestinal relative abundance of E. coli was associated with an increased incidence of SBAI, whereas B. obeum and I. timonensis were associated with improved overall survival. These findings identify gut microbial biomarkers that may help guide new preventive and therapeutic strategies for severe cirrhosis, particularly through the development of live biotherapeutic products. This study was funded under the 2016 PHRC program (PHRCN-16-0015).</p>
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              <p>IntroductionLa dysbiose intestinale est associée à la physiopathologie de la cirrhose et à ses complications. Le mécanisme d’action de la rifaximine (RFX) sur le microbiote intestinal reste mal connu. Le but de cette étude est de comparer l’effet de la RFX sur le microbiome intestinal à un placebo (PBO) et d’identifier des biomarqueurs microbiens associés à des changements de sévérité de la maladie, la survie, et l’incidence des infections spontanées du liquide d’ascite (ISLA) à partir des données de l’étude randomisée ProPILA-Rifax (NCT03069131).Patients et MéthodesOnt été inclus 42 patients ayant une cirrhose sévère, traités pendant 12 mois par RFX (n=21) ou PBO (n=21). Des échantillons de selles ont été collectés à J1, M3, M6, M12, et M18. L’ADN microbien a été extrait et des bibliothèques ciblant le gène 16s rRNA ont été préparées puis amplifiées pour séquençage Illumina. Le profil longitudinal du microbiote a été caractérisé à partir des amplicons via un pipeline bioinformatique. La richesse, la diversité et la composition du microbiote ont été analysées à l’aide de modèles linéaires mixtes prenant en compte l’effet aléatoire inter-patient. Des biomarqueurs microbiens associés au score Child-Pugh ont été identifiés et utilisés pour stratifier les patients, à partir desquels des courbes de survie et des analyses d’incidence d’ISLA ont été générées.RésultatsLa prise de RFX était associée à une diminution de la richesse du microbiote intestinal par rapport au baseline au cours des périodes de suivi (P &amp;lt; 0.001), alors qu’aucun changement n’a été observé dans le groupe PBO (P &amp;gt; 0.05). La diversité du microbiote était modifiée au cours du suivi des patients du bras RFX (R² = 0.068 ; P = 0.001), alors qu’aucun changement n’a été observé dans le groupe PBO (R² = 0.038 ; P = 0.2). L’abondance relative d’espèces bactériennes (e.g., Ruminococcus bromii et Roseburia inulinivoran) diminuaient spécifiquement au cours du suivi dans le bras RFX. L’abondance relative de certaines espèces associées à la cirrhose diminuaient dans le bras RFX, comme Escherichia coli (P = 0.002) et Veillonella parvula (P = 0.005), à l’inverse des espèces Blautia obeum (P = 0.03) et Fusicatenibacter saccharivorans (P = 0.004), dont l’abondance relative augmentaient. Le traitement par  RFX augmente la proportion des E. coli résistants à la rifampicine (P &amp;lt; 0.001), sans qu’aucune résistance croisée à la ciprofloxacine et au céfotaxime n’ait été observée. Dans le modèle mixte évaluant l’association entre le score Child-Pugh et l’abondance relative des espèces bactériennes, plusieurs taxons du phylum Firmicutes (notamment Streptococcus spp. et Veillonella spp.) étaient positivement corrélés à la sévérité de la cirrhose. Les analyses de Cox stratifiées ont montré que les patients dont le microbiote était enrichi en E. coli ou V. parvula présentaient un risque accru de développer une ISLA. Les analyses de survie stratifiés montrent que les patients dont le microbiote est enrichi en B. obeum et Intestinomonas timonensis ont une survie globale plus élevée que ceux sous-exprimant ces bactéries (respectivement n=17, P = 0.002 ; n=13, P = 0.01). Conclusion : La RFX diminue l’abondance relative d’espèces associées à la cirrhose et d’espèces commensales, sans avoir d’effet bénéfique sur la survie à 12 mois ou l’incidence des ISLA sur cette population de patients cirrhotiques sévères. Dans cette cohorte, l’abondance relative intestinale d’E. coli est associé à une augmentation de l’incidence de l’ISLA, alors que celles de B. obeum et I. timonensis sont associés à une survie globale plus élevée. Ces résultats identifient des biomarqueurs du microbiote intestinal qui pourraient guider de nouvelles stratégies de prévention et de traitement de la cirrhose sévère, notamment par le développement de produits biothérapeutiques vivants.</p>
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