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The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | The control group will include patients who will be monitored for their progress while receiving standard treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Biological | Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | At one month post-FMT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Birlutiu, Prof. Dr. | County Clinical Emergency Hospital of Sibiu | Study Chair |
| Adrian Boicean, Prof. Dr. | County Clinical Emergency Hospital of Sibiu | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| County Clinical Emergency Hospital of Sibiu | Sibiu | 550245 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38001930 | Background | 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. | |
| 40863438 | Background | 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. |
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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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Liver Cirrhosis
Patients were recruited from the Sibiu County Emergency Clinical Hospital, Romania.
Inclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis | 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. |
| FG001 | Control | The control group will include patients who will be monitored for their progress while receiving standard treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis | 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. Fecal microbiota transplantation: Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Median | Inter-Quartile Range | kPa | At one month post-FMT. |
|
Adverse events were monitored at multiple time points: 6 hours, 1 week, 1 month, and 3 months post-intervention.
Adverse events (AEs) included any untoward medical occurrence temporally associated with fecal microbiota transplantation. Serious AEs (SAEs) included life-threatening events, hospitalization, or permanent disability. AEs were collected at 6 hours, 1 week, 1 month, and 3 months. No major colonoscopy-related complications occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fecal Microbiota Transplantation (FMT) in Patients With Liver Cirrhosis | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor Adverse Event | Gastrointestinal disorders | Systematic Assessment | Abdominal discomfort |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ichim Cristian | County Clinical Hospital Sibiu | 0040771643848 | cristian.ichim@ulbsibiu.ro |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2023 | Mar 6, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2023 | Mar 6, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D006501 | Hepatic Encephalopathy |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
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|
| 40943741 | Result | 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. |
| 41464526 | Result | 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. |
| BG001 | Control | The control group will include patients who will be monitored for their progress while receiving standard treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | All enrolled participants self-identified as Caucasian. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fibrosis | Full Scale Name and Construct: Liver stiffness measured by transient elastography (FibroScan) Scale Ranges and Interpretation: Possible values: 2.5-75 kPa (device-dependent) Lower values: indicate less fibrosis and healthier liver tissue Higher values: indicate more severe fibrosis and worse liver stiffness Score Computation: Each participant's liver stiffness is reported as the median of valid measurements, with the interquartile range (IQR) showing measurement variability. Unit of Measure: kPa | Median | Inter-Quartile Range | kPa |
|
| Encephalopathy | Hepatic encephalopathy is assessed using: West Haven Criteria (WHC) Grade 0: No abnormality Grade 1: Mild cognitive changes, subtle personality or behavior changes Grade 2: Obvious disorientation, asterixis may be present Grade 3: Severe disorientation, somnolence Grade 4: Coma Lower grades indicate better neurological function; higher grades indicate worse encephalopathy | Count of Participants | Participants |
|
| OG001 | Control | The control group will include patients who will be monitored for their progress while receiving standard treatment. |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | At one month post-FMT. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Control | The control group will include patients who will be monitored for their progress while receiving standard treatment. | 0 | 13 | 0 | 13 | 0 | 13 |
|
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| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Hepatic Encephalopathy Grade 2 |
|