Patients With Nonalcoholic SteatohepatitisPhase 2EMOTIONNCT05622526
Evaluate the Efficacy, Safety and Tolerability of Fecal Microbiota Transfer for the Treatment of Patients With Nonalcoholic Steatohepatitis
A Phase 2 study testing Group 1 or Experimental group in people with Patients With Nonalcoholic Steatohepatitis, run by Instituto de Investigación Marqués de Valdecilla.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Nonalcoholic Steatohepatitis
- What is being tested?
- Group 1 or Experimental group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders aged between 18 and75 years old (both included).
- Body mass index (BMI) <40 kg/m2.
- Histological diagnosis of NASH, accepted by EASL and AASLD , from a liver biopsy obtained up to 24 weeks prior to the signing of the informed consent.
- NASH histologic activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation, and liver cell ballooning).
- Histologic evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 (perisinusoidal and portal/periportal fibrosis), or stage 3 (bridging fibrosis) as defined by the NASH CRN fibrosis score.
Who cannot join
- Evidence of other type of liver disease.
- History of high alcohol intake (daily consumption > 30 g/day for men and > 20 g/day for women).
- Weight change of more than 5% in the 3 months prior to screening.
- Subjects with HbA1c> 9.5%. For subjects with an HbA1c> 9.5% at the screening visit, a repeat test may be performed within the screening window.
- A repeated result of HbA1c> 9.5% will result in exclusion.
- Diabetic patients with:
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- Insulin treatment.
- Changes in antidiabetic medication in the 4 months prior to liver biopsy according to the following conditions:
- Modification of the dose of treatment with glucagon agonists type 1 (GLP-1).
- Implementation of treatment with a new antidiabetic.
- History of bariatric surgery.
- Cirrhosis.
- Portal thrombosis.
- Known or suspected hepatocellular carcinoma.
- Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease, as determined by the investigator.
- An estimated glomerular filtration rate (eGFR) <45 ml / min / 1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] method).
- Medical conditions that decrease life expectancy to less than 2 years, including cancer.
- Presence of an inherited or acquired immunodeficiency.
- Diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis, microscopic colitis), active irritable bowel syndrome (within the last 2 years according to Rome IV criteria), celiac disease not well controlled with a gluten-free diet, active gastroparesis, toxic megacolon.
- Major intra-abdominal surgery in the 2 months prior to randomization of the patient in the study.
- Antibiotic intake in the 8 weeks prior to the screening date.
- Probiotic/prebiotic/marketed synbiotic intake in the 4 weeks prior to the screening date.
- Pregnancy or lactation.
- Any other condition that, in the opinion of the investigator, could prevent or hinder compliance.
- Use of medication with potential steatogenic effect (corticosteroids, valproic acid, amiodarone and/or tamoxifen) within the 6 months prior to the first dose of study drug.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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:
- Screening phase with a duration of 12 weeks to classify patients based on lifestyle modifications.
- Treatment phase where patients will be randomized and stratified 2:1 to treatment:
- Experimental for n=64 patients.
- Placebo control for n=32 patients.
- Being tested
- Group 1 or Experimental group, Group 2 or Control group
- Keywords
- MetEH: metabolic hepatic steatosis, NASH nonalcoholic steatohepatitis, TMF: fecal microbiota transplantation
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 or Experimental groupDrug
Capsules of fecal microbiota transplantation
Group 2 or Control groupOther
capsules of placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 or Experimental group | Experimental | 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). Receives: Drug: Group 1 or Experimental group |
| Group 2 or Control group | Placebo comparator | 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) Receives: Other: Group 2 or Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
Measured: 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
Measured: 72 weeks
Secondary outcomes (6)
Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.
Measured: 72 weeks
NAFLD Fibrosis score
Measured: 72 weeks
Changes in weight, BMI.
Measured: 72 weeks
Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.
Measured: 72 weeks
Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.
Measured: 72 weeks
patient-reported outcomes
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Jan 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622526
- Sponsor's protocol ID
- EMOTION
- Acronym
- EMOTION
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05622526
- Acronym / sponsor ID
- EMOTION / EMOTION
- Keywords
- MetEH: metabolic hepatic steatosis, NASH nonalcoholic steatohepatitis, TMF: fecal microbiota transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening phase with a duration of 12 weeks to classify patients based on lifestyle modifications.
- Treatment phase where patients will be randomized and stratified 2:1 to treatment:
- Experimental for n=64 patients.
- Placebo control for n=32 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 or Experimental group | Experimental | Drug: Group 1 or Experimental grouptreatment 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). |
| Group 2 or Control group | Placebo comparator | Other: Group 2 or Control grouptreatment 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of both genders aged between 18 and75 years old (both included).
- Body mass index (BMI) <40 kg/m2.
- Histological diagnosis of NASH, accepted by EASL and AASLD , from a liver biopsy obtained up to 24 weeks prior to the signing of the informed consent.
- NASH histologic activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation, and liver cell ballooning).
- Histologic evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 (perisinusoidal and portal/periportal fibrosis), or stage 3 (bridging fibrosis) as defined by the NASH CRN fibrosis score.
Key exclusion criteria (25 listed)
- Evidence of other type of liver disease.
- History of high alcohol intake (daily consumption > 30 g/day for men and > 20 g/day for women).
- Weight change of more than 5% in the 3 months prior to screening.
- Subjects with HbA1c> 9.5%. For subjects with an HbA1c> 9.5% at the screening visit, a repeat test may be performed within the screening window.
- A repeated result of HbA1c> 9.5% will result in exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 or Experimental groupCapsules of fecal microbiota transplantation | Drug | Group 1 or Experimental group |
| Group 2 or Control groupcapsules of placebo | Other | Group 2 or Control group |
Primary outcome
Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis.
Time frame: 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
Time frame: 72 weeks
6 secondary outcomes
Proportion of patients with improvement (at least one point) in lobular swelling and/or ballooning without worsening of fibrosis.
Time frame: 72 weeks
NAFLD Fibrosis score
Time frame: 72 weeks
Changes in weight, BMI.
Time frame: 72 weeks
Changes in systolic and diastolic blood pressure, lipid profile, carotid ultrasound.
Time frame: 72 weeks
Changes in the quality of life questionnaire specific to chronic liver disease due to NAFLD.
Time frame: 72 weeks
patient-reported outcomes
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Group 1 or Experimental group in people with Patients With Nonalcoholic Steatohepatitis, run by Instituto de Investigación Marqués de Valdecilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Crespo (942315515, javiercrespo1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with improvement of fat fraction by proton density by MRI and no worsening of activity or fibrosis. (time frame: 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.