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Study of the faecal microbiota transfer in capsule form vs. placebo for the treatment of patients with non-alcoholic steatohepatitis
EU CTIS ID: 2022-500185-94-01
What this study is testing
- Assess the efficiency of the FMT in capsule form compared to the placebo regarding liver improvement passed 72 weeks in patients with NASH. - Assess the security and tolerability of the FMT in capsule form in patients with NASH during 72 weeks of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients of both genders between 18-75 years of age (both included)
- Body mass index <40 kg/m2
- NASH histological diagnosis, accepted by the EASL and the AASLD, of a liver biopsy obtained up to 24 weeks prior to signing the informed consent form
- NASH histological activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation and bulging of liver cells)
- Histological evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 fibrosis (perisinusoidal and portal/periportal fibrosis) or stage 3 fibrosis (bridging fibrosis) as defined by the NASH CRN fibrosis score
- In the case of women and men of childbearing age, for safety, those who agree to follow the required contraceptive measures after signing the informed consent form until the first visit of the follow-up period
You likely can't join if
- Evidence of having another type of liver disease
- Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, kidney, liver, respiratory, inflammatory, or infectious disease, according to what the investigator determines
- An estimated glomerular filtration rate (eGFR) <45 ml / min / 1,73 m2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration method [CKD-EPI])
- Medical conditions that lower life expectancy to less than 2 years, including cancer
- Presence of a hereditary or acquired immunodeficiency
- Inflammatory bowel disease diagnosis (Crohn’s disease, ulcerative colitis, microscopic colitis), active irritable bowel syndrome (in the last 2 years according to the Rome IV criteria), celiac disease not well controlled with a gluten-free diet, active gastroparesis, toxic megacolon
See the full eligibility criteria
Who can join
- Patients of both genders between 18-75 years of age (both included)
- Body mass index <40 kg/m2
- NASH histological diagnosis, accepted by the EASL and the AASLD, of a liver biopsy obtained up to 24 weeks prior to signing the informed consent form
- NASH histological activity score (NAS) ≥ 4, with a score of 1 or more in each subcomponent (steatosis, lobular inflammation and bulging of liver cells)
- Histological evidence of stage 1 fibrosis (with perisinusoidal or portal fibrosis), stage 2 fibrosis (perisinusoidal and portal/periportal fibrosis) or stage 3 fibrosis (bridging fibrosis) as defined by the NASH CRN fibrosis score
- In the case of women and men of childbearing age, for safety, those who agree to follow the required contraceptive measures after signing the informed consent form until the first visit of the follow-up period
What rules you out
- Evidence of having another type of liver disease
- Clinically significant gastrointestinal, cardiovascular, neurological, psychiatric, metabolic, kidney, liver, respiratory, inflammatory, or infectious disease, according to what the investigator determines
- An estimated glomerular filtration rate (eGFR) <45 ml / min / 1,73 m2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration method [CKD-EPI])
- Medical conditions that lower life expectancy to less than 2 years, including cancer
- Presence of a hereditary or acquired immunodeficiency
- Inflammatory bowel disease diagnosis (Crohn’s disease, ulcerative colitis, microscopic colitis), active irritable bowel syndrome (in the last 2 years according to the 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 the randomization of the patient in the study
- Intake of antibiotics in the 8 weeks prior to the screening date
- Intake of commercialized probiotics/prebiotics/symbiotic in the 4 weeks prior to the screening date
- Pregnancy or breastfeeding
- Any other condition that, according to the investigator, could impede or hinder compliance
- High alcohol intake history (daily consumption > 30 g/day for men and > 20 g/day for women)
- Use of medication with a potential steatogenic effect (corticosteroids, valproic acid, amiodarone and/or tamoxifen) in the 6 months prior to the first dose of the study drug
- Weight loss of over 5% in the 3 months prior to the screening
- Subjects with HbA1c > 9,5%. In the case of subjects with an HbA1c > 9,5% during the selection visit, a repeated test can be performed during the window of selection. A repeated result of HbA1c > 9,5% shall result in exclusion
- Diabetic patients with: •Insulin treatment. • Changes in the antidiabetic medicine in the 4 months prior to the liver biopsy according to the following conditions: -Dose modification of the treatment with Glucagon- like peptide-1 (GLP-1) agonists. -Implementation of the treatment with a new antidiabetic
- History of bariatric surgery
- Cirrhosis
- Portal thrombosis
- Known or suspected hepatocellular carcinoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.