Liver CirrhosisPhase 3NCT06478602

Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis

A Phase 3 study testing Fecal microbiota transplantation in people with Liver Cirrhosis, run by Cristian Ichim at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Liver Cirrhosis
What is being tested?: Fecal microbiota transplantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteRomania
Study dates: 5 Aug 2024to 31 Mar 2025
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of liver cirrhosis according to current protocols.
Conscious and cooperative adult patients.

Who cannot join

Patients with hemodynamic and/or respiratory instability.
Patients with contraindications for colonoscopy or fecal transplantation.
Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
Associated oncological pathology.
Patients with other causes of severe immunodeficiencies.
Lack of compliance with the conditions imposed by the research project.
Patients who do not sign the informed consent.

Trial locations and contacts

1 site in 1 country.

Romania1 site

County Clinical Emergency Hospital of Sibiu
Sibiu, 550245

Other trials in Romania

About this study

The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).

Read the detailed description

Participants in the experimental group will receive fecal microbiota transplantation (FMT) from a screened healthy donor. Each patient will undergo colonoscopic delivery of a minimum of 70 grams of donor fecal material into the cecum. The study will assess outcomes by monitoring clinical status, laboratory tests, imaging results and stool analyses (including assessment of micro-RNA profiles), comparing changes from baseline and with the control group. Participants will undergo scheduled re-evaluations at approximately 1 month post-transplant (timing may vary slightly due to clinical or logistical considerations).

Conditions: Liver Cirrhosis
Being tested: Fecal microbiota transplantation
Keywords: Liver Cirrhosis, Fecal microbiota transplantation, FMT, Chronic liver disease, Cirrhosis complications, micro-RNA, Fibrosis, Hepatic encephalopathy
Medical subject headings: Liver Cirrhosis, Fibrosis, Hepatic Encephalopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fecal microbiota transplantationBiological
Also called Colonoscopy
Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.

Study groups in NCT06478602
Study group	Role	What they receive
Fecal microbiota transplantation (FMT) in patients with liver cirrhosis	Experimental	The experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope. Receives: Biological: Fecal microbiota transplantation
Control	No intervention	The control group will include patients who will be monitored for their progress while receiving standard treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Liver Stiffness by Transient Elastography (FibroScan)
Liver fibrosis was assessed using transient elastography (FibroScan) one month after fecal microbiota transplantation (FMT). Liver stiffness values, expressed in kilopascals (kPa), were used to quantify fibrosis. Multiple measurements were taken per participant, and the median value was reported. Lower kPa values indicate less fibrosis (better outcome), while higher values indicate more severe fibrosis (worse outcome).
Measured: At one month post-FMT.
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy
Hepatic encephalopathy (HE) was monitored in all participants at one month after fecal microbiota transplantation (FMT) using the West Haven criteria (Grade 0-IV). Higher grades indicate more severe encephalopathy.
Measured: At one month post-FMT.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 202431 Mar 2025

First posted27 Jun 2024
Study start5 Aug 2024
Primary completion30 Dec 2024
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Liver CirrhosisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06478602
Sponsor's protocol ID: No: 3505/15.02.2023
Status last verified: Mar 2026
First submitted: 23 Jun 2024
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study results will be made public and other researchers will be able to receive the anonymized database upon reasonable request.

Publications

Boicean A, Birlutiu V, Ichim C, Brusnic O, Onisor DM. Fecal Microbiota Transplantation in Liver Cirrhosis. Biomedicines. 2023 Oct 30;11(11):2930. doi: 10.3390/biomedicines11112930.
PubMed 38001930
Ichim C, Boicean A, Anderco P, Todor SB, Hasegan A, Birsan S, Birlutiu V. MicroRNAs in Liver Cirrhosis: Diagnostic and Therapeutic Perspectives-A Comprehensive Review. J Pers Med. 2025 Aug 14;15(8):376. doi: 10.3390/jpm15080376.
PubMed 40863438
Ichim C, Boicean A, Todor SB, Anderco P, Birlutiu V. Fecal Microbiota Transplantation in Patients with Alcohol-Associated Cirrhosis: A Clinical Trial. J Clin Med. 2025 Aug 24;14(17):5981. doi: 10.3390/jcm14175981.
PubMed 40943741
Ichim C, Boicean A, Todor SB, Boeras I, Anderco P, Birlutiu V. Dynamics of Fecal microRNAs Following Fecal Microbiota Transplantation in Alcohol-Related Cirrhosis. J Clin Med. 2025 Dec 5;14(24):8623. doi: 10.3390/jcm14248623.
PubMed 41464526

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
ClinicalTrials.gov ID: NCT06478602
Acronym / sponsor ID: No: 3505/15.02.2023
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis, Fecal microbiota transplantation, FMT, Chronic liver disease, Cirrhosis complications, micro-RNA, Fibrosis, Hepatic encephalopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Cristian IchimUniversity, hospital or other
Study start: 5 Aug 2024 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 27 Jun 2024 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fecal microbiota transplantation (FMT) in patients with liver cirrhosis	Experimental	Biological: Fecal microbiota transplantationThe experimantal group will receive fecal transplantation from a healthy donor. The study results will be obtained from analyzing the progression observed in imaging and laboratory tests (blood and fecal matter) as well as the patients clinical condition - compared to the initial phase and the control group. Patients will undergo fecal transplantation using a minimum of 70 grams of material collected and tested from a healthy donor. The fecal matter will be transferred into the cecum using a colonoscope.
Control	No intervention	–The control group will include patients who will be monitored for their progress while receiving standard treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis of liver cirrhosis according to current protocols.
Conscious and cooperative adult patients.

Key exclusion criteria (7 listed)

Patients with hemodynamic and/or respiratory instability.
Patients with contraindications for colonoscopy or fecal transplantation.
Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
Associated oncological pathology.
Patients with other causes of severe immunodeficiencies.

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
Fecal microbiota transplantationAlso: ColonoscopyPerforming a colonoscopy with fecal microbiota transplantation at the level of the cecum.	Biological	Fecal microbiota transplantation (FMT) in patients with liver cirrhosis

Primary outcome

Liver Stiffness by Transient Elastography (FibroScan)
Time frame: At one month post-FMT.
Liver fibrosis was assessed using transient elastography (FibroScan) one month after fecal microbiota transplantation (FMT). Liver stiffness values, expressed in kilopascals (kPa), were used to quantify fibrosis. Multiple measurements were taken per participant, and the median value was reported. Lower kPa values indicate less fibrosis (better outcome), while higher values indicate more severe fibrosis (worse outcome).
Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy
Time frame: At one month post-FMT.
Hepatic encephalopathy (HE) was monitored in all participants at one month after fecal microbiota transplantation (FMT) using the West Haven criteria (Grade 0-IV). Higher grades indicate more severe encephalopathy.

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis	6	6
Control	13	13

Primary outcome: Liver Stiffness by Transient Elastography (FibroScan)

Time frame: At one month post-FMT.. Median (Inter-Quartile Range). Unit: kPa

Measure	Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis n = 6	Control n = 13
Value	22.6 (20.5 to 23.6)	23 (22.2 to 24.9)

Primary outcome: Implications of Fecal Microbiota Transplantation in Modulating Hepatic Encephalopathy

Time frame: At one month post-FMT.. Count of participants. Unit: Participants

Measure	Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis n = 6	Control n = 13
Hepatic Encephalopathy Grade 0	5	3
Hepatic Encephalopathy Grade 1	1	7
Hepatic Encephalopathy Grade 2	0	3

Adverse events

Time frame: Adverse events were monitored at multiple time points: 6 hours, 1 week, 1 month, and 3 months post-intervention.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Control	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 38001930Boicean A, Birlutiu V, Ichim C, Brusnic O, Onisor DM. Fecal Microbiota Transplantation in Liver Cirrhosis. Biomedicines. 2023 Oct 30;11(11):2930. doi: 10.3390/biomedicines11112930.
Background: PubMed 40863438Ichim C, Boicean A, Anderco P, Todor SB, Hasegan A, Birsan S, Birlutiu V. MicroRNAs in Liver Cirrhosis: Diagnostic and Therapeutic Perspectives-A Comprehensive Review. J Pers Med. 2025 Aug 14;15(8):376. doi: 10.3390/jpm15080376.
Results publication: PubMed 40943741Ichim C, Boicean A, Todor SB, Anderco P, Birlutiu V. Fecal Microbiota Transplantation in Patients with Alcohol-Associated Cirrhosis: A Clinical Trial. J Clin Med. 2025 Aug 24;14(17):5981. doi: 10.3390/jcm14175981.
Results publication: PubMed 41464526Ichim C, Boicean A, Todor SB, Boeras I, Anderco P, Birlutiu V. Dynamics of Fecal microRNAs Following Fecal Microbiota Transplantation in Alcohol-Related Cirrhosis. J Clin Med. 2025 Dec 5;14(24):8623. doi: 10.3390/jcm14248623.
Individual participant dataSharing planned: No. The study results will be made public and other researchers will be able to receive the anonymized database upon reasonable request.

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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.

Victoria Birlutiu, Prof. Dr. study chair

County Clinical Emergency Hospital of Sibiu

Adrian Boicean, Prof. Dr. study director

County Clinical Emergency Hospital of Sibiu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fecal microbiota transplantation in people with Liver Cirrhosis, run by Cristian Ichim at 1 site in Romania.

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 2 inclusion and 7 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver Stiffness by Transient Elastography (FibroScan) (time frame: At one month post-FMT.). 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?

On the ClinicalTrials.gov record for NCT06478602, which also lists 4 linked publications.

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 27 Mar 2026.