Encapsulated Fecal Microbiota Transfer to Treat Immune Activation in Patients with Cirrhosis and Ascites (TransImmune) – A randomized, double-blind, placebo-controlled phase IIa clinical pilot study

Phase 1

• Conditions: cirrhosis and ascites; MedDRA version: 20.0Level: LLTClassification code: 10009213Term: Cirrhosis of liver Class: 10019805; MedDRA version: 20.0Level: SOCClassification code: 10019805Term: Hepatobiliary disorders Class: 15; MedDRA version: 20.0Level: PTClassification code: 10019641Term: Hepatic cirrhosis Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-507790-18-00
• Lead Sponsor: niversitaetsklinikum Aachen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-07
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified