EMOTION
Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer by Capsules vs. Placebo for the Treatment of Patients With Nonalcoholic Steatohepatitis
Sponsor study identifier
interventional
96
0 countries
N/A
Study Start
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The EMOTION study is a multicentric, double-blind, controlled, parallel-group, phase IIa randomized Clinical trial to evaluate the efficacy, safety and tolerability of TMF capsules for the treatment of patients with NASH. The clinical trial has two stages:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 21, 2022
Actual (reported)November 18, 2022
Actual (reported)January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
72 weeks
number of adverse events (AEs), serious AEs, AEs resulting in discontinuation of study treatment, AEs of special interest, and changes in vital signs and laboratory values
72 weeks
Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.
72 weeks
NAFLD Fibrosis score
72 weeks
Changes in weight, BMI.
72 weeks
Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.
72 weeks
Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.
72 weeks
treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months (4 maintenance doses).
treatment with an initial dose of 24 oral capsules of MBK-01 and a maintenance dose of 12 oral capsules of MBK-01 every 3 months for 12 months (4 maintenance doses)
Capsules of fecal microbiota transplantation
capsules of placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Submitted
September 21, 2022
First Posted
November 18, 2022
Study Start
January 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
November 1, 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 1, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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