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| ID | Type | Description | Link |
|---|---|---|---|
| Bando RF-2021-12373311 | Other Grant/Funding Number | Ministero della Salute |
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The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.
The study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list.
Enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation.
The intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. Fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. Gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. Moreover, clinical and microbiota assessments will be performed after liver transplantation. All other planned assessments are part of the normal course of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heterologous FMT | Experimental | Heterologous feces will be processed from routinely screened universal donors. Adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for Fecal Microbiota Transplantation. Fecal material must be infused by enema or colonoscopy. |
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| Homologous FMT | Placebo Comparator | The control arm will undergo autologous FMT after enrollment. Autologous feces will be collected by each patient the day before each FMT in both study arms. This will guarantee adequate patients' stool collection in order to subsequently store the fecal samples for autologous FMT and ensure blinding. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation (FMT) | Procedure | To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT. | Incidence of clinically severe infections (sepsis, severe sepsis, septic shock) | At 6 months after OLT |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events after FMT | To evaluate the safety profile of both heterologous and autologous FMT in patients enlisted for OLT and the relationship between fecal microbiota composition and the gastrointestinal permeability profile before and after FMT. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Barbara, MD | Contact | +390512144103 | giovanni.barbara@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Giovanni Barbara, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | 40138 | Italy |
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All adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for inclusion in the present study. Study enrollment will start after the favorable opinion of the Ethics Committee and the authorization by the General Manager of IRCCS AOUBO, in May 2023, indicatively, and will last 24 months.
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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