Fecal Microbiota TransplantationNCT06782880
Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation
A study testing Fecal microbiota transplantation (FMT) in people with Fecal Microbiota Transplantation and Orthotopic Liver Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota Transplantation, Orthotopic Liver Transplantation, Multi-drug Resistant Bacteria
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age≥18 years) patients listed for OLT for various etiologies.
- Patient's consent to participate in the study
Who cannot join
- Previous total colectomy
- Pregnancy or breastfeeding
- Patients on oral or intravenous antimicrobial agents
- HIV positive and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3
- Active SARS-CoV-2 infection
- Neutropenia <0.5X10^9/L
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- Toxic megacolon
- Contraindications to colonoscopy
- Any conditions for which, according to the physician, FMT endangers the patient's health
- History of hypersensitivity to macrogol contained in bowel preparations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Giovanni Barbara, MD, +390512144103, giovanni.barbara@unibo.it
Giovanni Barbara, MD
About this study
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
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.
Read the detailed description
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.
- Conditions
- Fecal Microbiota Transplantation, Orthotopic Liver Transplantation, Multi-drug Resistant Bacteria
- Being tested
- Fecal microbiota transplantation (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Procedure or surgery
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fecal microbiota transplantation (FMT) |
| 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. Receives: Procedure: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 6 months after OLT
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 May 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Barbara, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782880
- Sponsor's protocol ID
- FMT-OLT
- Other IDs
- Bando RF-2021-12373311
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
- ClinicalTrials.gov ID
- NCT06782880
- Acronym / sponsor ID
- FMT-OLT
- Conditions
- Fecal Microbiota Transplantation, Orthotopic Liver Transplantation, Multi-drug Resistant Bacteria
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heterologous FMT | Experimental | Procedure: Fecal microbiota transplantation (FMT)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. |
| Homologous FMT | Placebo comparator | Procedure: Fecal microbiota transplantation (FMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (age≥18 years) patients listed for OLT for various etiologies.
- Patient's consent to participate in the study
Key exclusion criteria (10 listed)
- Previous total colectomy
- Pregnancy or breastfeeding
- Patients on oral or intravenous antimicrobial agents
- HIV positive and not well controlled on antiretroviral therapy, or CD4+ <200/ mm3
- Active SARS-CoV-2 infection
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 transplantation (FMT)To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT. | Procedure or surgery | Heterologous FMT, Homologous FMT |
Primary outcome
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
Time frame: At 6 months after OLT
Incidence of clinically severe infections (sepsis, severe sepsis, septic shock)
1 secondary outcome
Incidence of adverse events after FMT
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Giovanni Barbara, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation (FMT) in people with Fecal Microbiota Transplantation and Orthotopic Liver Transplantation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 10 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. 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 Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Barbara, MD (+390512144103, giovanni.barbara@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT. (time frame: At 6 months after OLT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.