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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Aachen AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

1 Aug 2025 → ongoing

Decision date (initial)

2024-08-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

To evaluate the safety of FMT capsules for the treatment of immune activation in patients with cirrhosis and ascites.

Secondary objectives 1

1. To evaluate signals of clinical efficacy of FMT capsules for the treatment of immune activation in patients with cirrhosis and ascites.

Conditions and MedDRA coding

cirrhosis and ascites

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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

Exclusion criteria 16

1. Subject has acute-on-chronic liver failure (ACLF) grade 2 or higher according to the EASL-CLIF Consortium definition.
2. Subject has Model for End-Stage Liver Disease (MELD) score >20.
3. Subject has received systemic antibiotics within 7 days prior to study inclusion, except for stable doses of norfloxacin or rifaximin.
4. Subject has active malignancy or history of malignancy, which was not curatively treated (excluding non-melanoma skin cancer).
5. Subject receives treatment with immunomodulatory drugs, including corticosteroids, thiopurines, calcineurin inhibitors, and mycophenolate currently or within 90 days prior to study inclusion.
6. Subject has a history of hypersensitivity or allergies to the investigational capsule coating substances or to any compound of INTESTIFIX 001 or placebo.
7. Subject has an expected lack of compliance.
8. Subject has a life expectancy of less than six months.
9. Subject is pregnant or breastfeeding.
10. Subject is not willing to take adequately safe contraceptive measures.
11. 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.
12. There is a current or past medically relevant disease or treatment that could influence the evaluation of the study.
13. Subject has received an investigational drug in another study within the last 30 days before study inclusion.
14. Concurrent participation in another clinical intervention study.
15. Subject is institutionalized due to an official or court order.
16. Subject is in a dependent relationship or employment relationship with the sponsor or investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The occurrence of serious adverse event (SAE) up to the end of the study (EOS).
2. The occurrence and its severity of treatment-emergent adverse events (TEAE) and adverse events (AE).

Secondary endpoints 5

1. 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).
2. Gut inflammation: Differences in faecal calprotectin between baseline (day 0) and V3 (day 7±2), V4 (day 28±3), and EOS (day 90+14).
3. 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).
4. Quality of life: Differences in EQ-5D-5L and CLDQ score between baseline (day 0) and EOS (day 90+14.
5. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Aachen AöR

Sponsor organisation

Universitaetsklinikum Aachen AöR

Address

Pauwelsstrasse 30

City

Aachen

Postcode

52074

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Univ.-Prof. Dr. med. habil. Tony Bruns

Public contact point

Organisation

Universitaetsklinikum Aachen AöR

Contact name

Dr. Rainer Schuckelt

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications