HealthyNCT04222153
Innovative Approach to Fecal Microbiota Transplantation (FMT) Applied for Chronic Kidney Disease (CKD)
An observational study of Healthy and Chronic Kidney Diseases, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
The aim of this PhD project focuses on the relationship between intestinal microbiota and health in the background of Chronic Kidney Disease (CKD). Many pathologies, including the CKD, display a dysbiosis of the intestinal microbiota, which is at the same time a consequence of CKD and contributes to its progression… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Kidney Diseases
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2019to 26 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is composed by healthy volunteers, aged between 18 and 50, with normal BMI and characterized by omnivorous diet.
Who may be able to join
- Healthy subjects
- Aged between 18 and 50
- BMI between 18.5-25
- Omnivorous diet
- Informed consent signed
Who cannot join
- Health workers (to exclude the risk of transmission of multi-resistant organisms)
- Type 2 diabetes mellitus
- Hypertension
- Chronic liver disease
- Chronic gastrointestinal disorders
- Systemic inflammatory disorders
Show all 24Show fewer
- Suspected, clinical diagnosis or previous history of malignancies (<5 years)
- Therapies with corticosteroids or immunosuppressive drugs
- Autoimmune disorders
- Previous history of organ / tissue transplantation
- Prior gastrointestinal surgery (eg gastric bypass)
- eGFR lower than 60ml / minute and / or diagnosis of nephropathy
- Previous acute major cardiovascular diseases (myocardial infarction, stroke)
- History of C. difficile infections
- Known systemic infection not controlled
- Previous use of antibiotics (<3 months)
- Recent appearance of diarrhea
- Chronic use of laxatives or chronic diarrhea
- Chronic constipation
- Recurrent urinary tract infections (3 cases per year)
- Use of proton pump inhibitors in the last 3 months
- Recent use of probiotics or other aids (drugs / supplements) for the regulation of gastrointestinal activity (<3 months)
- Pregnancy and breastfeeding
- Psychiatric conditions that reduce compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Approccio Innovativo di Trapianto di Microbiota Fecale Applicato Alla Malattia Renale Cronica
The aim of this PhD project focuses on the relationship between intestinal microbiota and health in the background of Chronic Kidney Disease (CKD). Many pathologies, including the CKD, display a dysbiosis of the intestinal microbiota, which is at the same time a consequence of CKD and contributes to its progression and complication. In a variety of chronic-degenerative and infectious diseases, the "fecal microbiota transplantation" (FMT) is being tested in recent years in addition with the application of both probiotics and prebiotics. FMT is indeed currently successfully used in the eradication of recurrent Clostridium difficile infections, with success rates of 90%, thus recent evidence suggests that FMT could be applied in other diseases characterized by microbiota dysbiosis, such as CKD and diabetes, in which the FMT has never been previously tested.
This project will allow to study:
- the prototypal production of the encapsulated suspension of healthy microbiota tested in a minimally invasive FMT procedure (by oral administration); ii) the efficacy of the innovative prototype for colonization and modulation of intestinal microbiota following FMT; iii) the experimental and clinical feedback of this suspension, by in vivo studies.
Read the detailed description
This project will allow to experiment the Fecal microbiota transplantation in the CKD model and to set up a pharmaceutical formulation of fecal suspensions of microbiota.
Firstly, a collection of fecal samples from healthy volunteers will be set up, with the aim to collect biological samples. Screening and enrollment of healthy volunteers, gathering personal and clinical information together with eating habits, will be performed.
The best product design in efficacy, stability over time as well as suitable excipients and any other active components able to perform a synergistic action will be evaluated. After defining the pharmaceutical formulation, the production of the prototype will be finalized.
In a second time in vivo studies on a model of CKD (uremic mouse with CKD induced by 5/6 nephrectomy) will be designed and carried on. The CKD model will be used to evaluate the effects and the outcomes of FMT on clinical parameters such as renal function, circulating levels of uremic toxins, state and function of the intestinal microbiota, intestinal permeability and microbiota composition. This step will be necessary to establish the efficacy of the innovative prototype for the colonization and the modulation of intestinal microbiota following FMT.
- Conditions
- Healthy, Chronic Kidney Diseases
- Keywords
- Fecal Microbiota Transplantation (FMT), Gut microbiota, Uremic toxins
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers enrolled according to the procedures of the FMT01 protocol
A final number of 10 healthy volunteers will be selected to collect their fecal samples, according to the protocol FMT01 (ref. Cammarota G et al. Gut 2017 doi:10.1136/gutjnl-2016-313017):
- Preliminary interview - anamnestic interview to exclude people with history of disease and risk factors
- Secondary interview - anamnestic interview (on the day of donation) to exclude donors with recently appeared harmful issues
- Sample collection - blood and stool testing to verify the presence of potentially transmittable disease: Cytomegalovirus, Epstein-Barr virus, Hepatitis A, HBV, HCV, Syphilis, HIV-1 and HIV-2, Faecal Helicobacter pylori, Faecal occult blood testing, Fecal ova and parasites Steps 1 and 2 will be analyzed by the physician in order to exclude people, after enrollment, at risk of potential harmful issues. People passing steps 1 and 2 will undergo blood and fecal laboratory screening. Positivity to one or more of the tested factor will result in volunteer exclusion.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start26 Nov 2019
- Primary completion26 Feb 2020
- Study completion26 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Responsible party
- Sponsor
- Investigators
- Loreto Gesualdo, MD Full Prof, Principal investigator, Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222153
- Sponsor's protocol ID
- FMT01
- Status last verified
- Jan 2020
- First submitted
- 4 Dec 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approccio Innovativo di Trapianto di Microbiota Fecale Applicato Alla Malattia Renale Cronica
- ClinicalTrials.gov ID
- NCT04222153
- Acronym / sponsor ID
- FMT01
- Conditions
- Healthy, Chronic Kidney Diseases
- Keywords
- Fecal Microbiota Transplantation (FMT), Gut microbiota, Uremic toxins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Dec 2021 (actual)
- First posted
- 9 Jan 2020 (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 aim of this PhD project focuses on the relationship between intestinal microbiota and health in the background of Chronic Kidney Disease (CKD). Many pathologies, including the CKD, display a dysbiosis of the intestinal microbiota, which is at the same time a consequence of CKD and contributes to its progression and complication. In a variety of chronic-degenerative and infectious diseases, the "fecal microbiota transplantation" (FMT) is being tested in recent years in addition with the application of both probiotics and prebiotics. FMT is indeed currently successfully used in the eradication of recurrent Clostridium difficile infections, with success rates of 90%, thus recent evidence suggests that FMT could be applied in other diseases characterized by microbiota dysbiosis, such as CKD and diabetes, in which the FMT has never been previously tested.
This project will allow to study:
- the prototypal production of the encapsulated suspension of healthy microbiota tested in a minimally invasive FMT procedure (by oral administration); ii) the efficacy of the innovative prototype for colonization and modulation of intestinal microbiota following FMT; iii) the experimental and clinical feedback of this suspension, by in vivo studies.
Detailed description
This project will allow to experiment the Fecal microbiota transplantation in the CKD model and to set up a pharmaceutical formulation of fecal suspensions of microbiota.
Firstly, a collection of fecal samples from healthy volunteers will be set up, with the aim to collect biological samples. Screening and enrollment of healthy volunteers, gathering personal and clinical information together with eating habits, will be performed.
The best product design in efficacy, stability over time as well as suitable excipients and any other active components able to perform a synergistic action will be evaluated. After defining the pharmaceutical formulation, the production of the prototype will be finalized.
In a second time in vivo studies on a model of CKD (uremic mouse with CKD induced by 5/6 nephrectomy) will be designed and carried on. The CKD model will be used to evaluate the effects and the outcomes of FMT on clinical parameters such as renal function, circulating levels of uremic toxins, state and function of the intestinal microbiota, intestinal permeability and microbiota composition. This step will be necessary to establish the efficacy of the innovative prototype for the colonization and the modulation of intestinal microbiota following FMT.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is composed by healthy volunteers, aged between 18 and 50, with normal BMI and characterized by omnivorous diet.
Key inclusion criteria (5 listed)
- Healthy subjects
- Aged between 18 and 50
- BMI between 18.5-25
- Omnivorous diet
- Informed consent signed
Key exclusion criteria (24 listed)
- Health workers (to exclude the risk of transmission of multi-resistant organisms)
- Type 2 diabetes mellitus
- Hypertension
- Chronic liver disease
- Chronic gastrointestinal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of healthy volunteers enrolled according to the procedures of the FMT01 protocol
Time frame: 2 months
A final number of 10 healthy volunteers will be selected to collect their fecal samples, according to the protocol FMT01 (ref. Cammarota G et al. Gut 2017 doi:10.1136/gutjnl-2016-313017): 1. Preliminary interview - anamnestic interview to exclude people with history of disease and risk factors 2. Secondary interview - anamnestic interview (on the day of donation) to exclude donors with recently appeared harmful issues 3. Sample collection - blood and stool testing to verify the presence of potentially transmittable disease: Cytomegalovirus, Epstein-Barr virus, Hepatitis A, HBV, HCV, Syphilis, HIV-1 and HIV-2, Faecal Helicobacter pylori, Faecal occult blood testing, Fecal ova and parasites Steps 1 and 2 will be analyzed by the physician in order to exclude people, after enrollment, at risk of potential harmful issues. People passing steps 1 and 2 will undergo blood and fecal laboratory screening. Positivity to one or more of the tested factor will result in volunteer exclusion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Loreto Gesualdo, MD Full Prof principal investigator
Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Chronic Kidney Diseases, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 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 5 inclusion and 24 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 8 Feb 2023. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of healthy volunteers enrolled according to the procedures of the FMT01 protocol (time frame: 2 months). 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 8 Feb 2023.