Encapsulated Fecal Microbiota Transfer to Treat Immune Activation in Patients with Cirrhosis and Ascites (TransImmune) – A randomized, double-blind, placebo-controlled phase IIa clinical pilot study

cirrhosis and ascites

The occurrence of serious adverse event (SAE) up to the end of the study (EOS)., The occurrence and its severity of treatment-emergent adverse events (TEAE) and adverse events (AE).

Systemic inflammation: Differences in white blood cell count, C-reactive protein, procalcitonin, and IL-6 between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14)., Gut inflammation: Differences in faecal calprotectin between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14)., Organ dysfunction: Differences in Child-Pugh score, Model of End Stage Liver Disease (MELD) score, Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF-SOFA / CLIF-C OF) score between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14)., Quality of life: Differences in EQ-5D-5L and CLDQ score between baseline (day 0) and EOS (day 90+14., Antibiotic-free days: Number of days without antibiotic use (except for oral use of norfloxacin or rifaximin) between baseline (day 0) and EOS (day 90+14).

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Germany