Randomized, double-blind and multicentric study to assess the efficiency, security and tolerability of the faecal microbiota transfer in capsule form vs. placebo for the treatment of patients with non-alcoholic steatohepatitis (EMOTION)

Conditions

non-alcoholic steatohepatitis

Brief summary

-Patient ratio with a NASH resolution without fibrosis worsening. -Patient ratio without fibrosis nor activity worsening. -Patient ratio with a MRI-PDFF betterment and without a fibrosis or activity worsening., Occurrence of adverse events (AE), severe AE (SAE), AE that result in the interruption of the study’s treatment, AE of special interest, and changes in the vital signs and the laboratory results during 72 weeks of treatment

Detailed description

Patient ratio with betterment regarding the lobular inflammation and/or ballooning without fibrosis worsening, Changes in fibrosis biomarkers, MRI-PDFF, Changes in anthropometric measurements, Changes in lipid profile, Changes in inflammation biomarkers, Changes in insulin resistance, Changes in vital signs, Changes in emerging CVR factors, Changes in the carotid ultrasound, Changes in the SF-36 questionnaire, Changes in the CLDQ-NAFLD questionnaire

Related papers

No related papers found yet.

Interventions

DRUGmicrocrystalline cellulose Ph Eur

DRUGin hypromellose capsules

DRUGLyophilized capsules of fecal microbiota

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
-Patient ratio with a NASH resolution without fibrosis worsening. -Patient ratio without fibrosis nor activity worsening. -Patient ratio with a MRI-PDFF betterment and without a fibrosis or activity worsening., Occurrence of adverse events (AE), severe AE (SAE), AE that result in the interruption of the study’s treatment, AE of special interest, and changes in the vital signs and the laboratory results during 72 weeks of treatment	—

Measure

Time frame