Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
NCT ID: NCT06478602
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
30 participants
INTERVENTIONAL
2023-02-15
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Control
The control group will include patients who will be monitored for their progress while receiving standard treatment.
No interventions assigned to this group
Interventions
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Fecal microbiota transplantation
Performing a colonoscopy with fecal microbiota transplantation at the level of the cecum.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Conscious and cooperative adult patients.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Cristian Ichim
OTHER
Responsible Party
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Cristian Ichim
Principal Investigator
Principal Investigators
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Victoria Birlutiu, Prof. Dr.
Role: STUDY_CHAIR
County Clinical Emergency Hospital of Sibiu
Adrian Boicean, Prof. Dr.
Role: STUDY_DIRECTOR
County Clinical Emergency Hospital of Sibiu
Locations
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County Clinical Emergency Hospital of Sibiu
Sibiu, , Romania
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Boicean A, Ichim C, Todor SB, Anderco P, Popa ML. The Importance of Microbiota and Fecal Microbiota Transplantation in Pancreatic Disorders. Diagnostics (Basel). 2024 Apr 23;14(9):861. doi: 10.3390/diagnostics14090861.
Boicean A, Birlutiu V, Ichim C, Anderco P, Birsan S. Fecal Microbiota Transplantation in Inflammatory Bowel Disease. Biomedicines. 2023 Mar 27;11(4):1016. doi: 10.3390/biomedicines11041016.
Other Identifiers
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No: 3505/15.02.2023
Identifier Type: -
Identifier Source: org_study_id
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