INTESTIFIX for Liver cirrhosis | Ascites

Inclusion criteria

• {"criterion_text":"- Subject has cirrhosis of any etiology based on clinical standard criteria, imaging findings, and/or histology."}
• {"criterion_text":"- Subject is diagnosed with ascites and has undergone paracentesis or diagnostic ascitic tap within the last 30 days prior to study inclusion."}
• {"criterion_text":"- Subject age is between 18 and 70 years at the time of study inclusion."}
• {"criterion_text":"- Subject is able to swallow the Investigational Medicinal Product (IMP) Fecal Microbiota Transfer capsules or placebo."}
• {"criterion_text":"- Subject is mentally and physically able to understand the significance and scope of the study and to comply with the study protocol."}
• {"criterion_text":"- A written informed consent form has been signed prior to participation in the study."}

Exclusion criteria

• {"criterion_text":"- Subject has acute-on-chronic liver failure (ACLF) grade 2 or higher according to the EASL-CLIF Consortium definition."}
• {"criterion_text":"- Subject is not willing to take adequately safe contraceptive measures."}
• {"criterion_text":"- Study participation is, at the discretion of the investigator, an unacceptable risk due to pre-existing or concomitant disease or due to the patient's general underlying condition."}
• {"criterion_text":"- There is a current or past medically relevant disease or treatment that could influence the evaluation of the study."}
• {"criterion_text":"- Subject has received an investigational drug in another study within the last 30 days before study inclusion."}
• {"criterion_text":"- Concurrent participation in another clinical intervention study."}
• {"criterion_text":"- Subject is institutionalized due to an official or court order."}
• {"criterion_text":"- Subject is in a dependent relationship or employment relationship with the sponsor or investigator."}
• {"criterion_text":"- Subject has Model for End-Stage Liver Disease (MELD) score >20."}
• {"criterion_text":"- Subject has received systemic antibiotics within 7 days prior to study inclusion, except for stable doses of norfloxacin or rifaximin."}
• {"criterion_text":"- Subject has active malignancy or history of malignancy, which was not curatively treated (excluding non-melanoma skin cancer)."}
• {"criterion_text":"- Subject receives treatment with immunomodulatory drugs, including corticosteroids, thiopurines, calcineurin inhibitors, and mycophenolate currently or within 90 days prior to study inclusion."}
• {"criterion_text":"- Subject has a history of hypersensitivity or allergies to the investigational capsule coating substances or to any compound of INTESTIFIX 001 or placebo."}
• {"criterion_text":"- Subject has an expected lack of compliance."}
• {"criterion_text":"- Subject has a life expectancy of less than six months."}
• {"criterion_text":"- Subject is pregnant or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- The occurrence of serious adverse event (SAE) up to the end of the study (EOS).","definition_or_measurement_approach":"Occurrence of SAEs measured up to end of study (EOS)."}
• {"endpoint_text":"- The occurrence and its severity of treatment-emergent adverse events (TEAE) and adverse events (AE).","definition_or_measurement_approach":"Occurrence and severity of TEAEs and AEs recorded and assessed (timeframe up to EOS as per protocol)."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Laboratory measures compared as change from baseline (day 0) to specified visits V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14)."}
• {"endpoint_text":"- Gut inflammation: Differences in faecal calprotectin between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14).","definition_or_measurement_approach":"Faecal calprotectin compared as change from baseline to V3, V4, and EOS per specified windows."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Clinical score changes from baseline to V3, V4, and EOS using standard scoring systems (Child-Pugh, MELD, CLIF-SOFA/CLIF-C OF)."}
• {"endpoint_text":"- Quality of life: Differences in EQ-5D-5L and CLDQ score between baseline (day 0) and EOS (day 90+14.","definition_or_measurement_approach":"Quality-of-life instruments (EQ-5D-5L and CLDQ) compared from baseline to EOS (day 90+14)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Count of days without antibiotic use (exclusions noted) between baseline and EOS (day 90+14)."}

Germany

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

596

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Universitaetsklinikum Aachen AöR

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Germany

Contract research organisations

Name

X-act Cologne Clinical Research GmbH

Responsibilities

sponsorDuties code 10

Third parties

• {"country":"Austria","full_name":"Medical University Of Graz","duties_or_roles":"sponsorDuties code 3","organisation_type":"Educational Institution"}
• {"country":"Germany","full_name":"X-act Cologne Clinical Research GmbH","duties_or_roles":"sponsorDuties code 10","organisation_type":"Laboratory/Research/Testing facility"}