Clostridium Difficile InfectionsPhase 3NCT06107569
Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma
A Phase 3 study testing Fecal microbiota transplant (Promicrobioma) and Antibiotic in people with Clostridium Difficile Infections, run by Hospital Universitario Evangelico de Curitiba.
Trial summary
The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infections
- What is being tested?
- Fecal microbiota transplant (Promicrobioma) and Antibiotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jan 2026
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
The inclusion criteria are:
- Over 18 years old;
- Hospitalized patients;
- Clinical and laboratory diagnosis of CDI;
- Signing the informed consent form
- For primary CDI, use of antibiotics for less than 72 hours; and for recurrent CDI, previous confirmed CDI with clinical response to antibiotic treatment and CDI recurrence within 8 weeks.
The exclusion criteria are:
- Pregnant patients
- Severe form of CDI requiring surgery
- Impossibility of performing the colonoscopy procedure or using a nasoenteral tube
About this study
Official title: Randomized Controlled Clinical Study of Treatment of Clostridioides Difficile Infection Comparing Fecal Microbiota Transplantation With Antibiotic Treatment
The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.
Read the detailed description
INTRODUCTION
The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.
Currently, pseudomembranous colitis has few treatment options: the main one is fidaxomicin, unavailable in Brazil, and other alternatives are vancomycin and metronidazole. However, refractoriness to alternative treatments may occur, with fecal transplantation also being an alternative. Additionally, fecal transplantation is often associated with better outcomes than drug alternatives, reaching more than 90% clinical success.
Fecal microbiota transplantation (FMT) can occur through different routes, for example, via nasoenteral tube, colonoscopy, oral capsules or enemas, with colonoscopy or capsules normally being apparently more effective than enemas and nasoenteral tubes. Furthermore, the preparation of stool samples can be either fresh or frozen, which do not influence the effectiveness of the treatment. Since 2020, the PUCPR Fecal Microbiota Bank has been carrying out validation studies of a product, PROMICROBIOMA, composed of freeze-dried human fecal microbiota, which has already tested its safety in a phase 1 study on consecutive patients in a convenience sample. To evaluate the effectiveness of the product, it is important to carry out a controlled and randomized clinical study comparing it with antimicrobial therapy.
HYPOTHESIS H0 - PROMICROBIOMA is equal to antibiotic treatment in primary or recurrent CDI H1 - PROMICROBIOME is superior to antibiotic treatment in primary or recurrent CDI H2 - PROMICROBIOME is inferior to antibiotic treatment in primary or recurrent CDI
MAIN GOAL
To evaluate the clinical outcome of patients with primary or recurrent CDI using PROMICROBIOMA compared to antimicrobial therapy.
METHODS
Study design
This is a randomized, controlled clinical study of patients with primary or recurrent CDI.
- Conditions
- Clostridium Difficile Infections
- Being tested
- Fecal microbiota transplant (Promicrobioma), Antibiotic
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplant (Promicrobioma)Other
Fecal microbiota transplant with Promicrobioma (freeze-dried isolated microbiota)
AntibioticDrug
Antibiotics for Clostridioides infection (oral vancomycin) or association of intravenous metronidazol for severe cases.
| Study group | Role | What they receive |
|---|---|---|
| Promicrobioma | Experimental | MIcrobiote tranplant Receives: Other: Fecal microbiota transplant (Promicrobioma) |
| Antibiotic (metronidazole or vancomycin) | Active comparator | Antibiotic commonly used for treatment of CDI, including oral vancomycin or metronidazol) Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Clinical cure is defined as absence of diarrhea, abdominal pain, clinical signs of infection (fever).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionsStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Evangelico de Curitiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Francisco Bondan Tuon, Hospital Universitario Evangelico de Curitiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107569
- Sponsor's protocol ID
- CDItransplant
- Status last verified
- Feb 2024
- First submitted
- 13 Oct 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study of Treatment of Clostridioides Difficile Infection Comparing Fecal Microbiota Transplantation With Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT06107569
- Acronym / sponsor ID
- CDItransplant
- Conditions
- Clostridium Difficile Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital Universitario Evangelico de CuritibaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 Oct 2023 (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 inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.
Detailed description
INTRODUCTION
The increasing inappropriate use of antimicrobials, in addition to increasing selective pressure and inducing environmental resistance, is also a risk factor for the development of Clostridioides difficile infection (CDI). The intestinal microbiota is mainly composed of the phyla Firmicutes, Bacteroidetes, Acinobacteria, Proteobacteria, Fusobacteria and Verrucomicrobia, and more than 90% of the phylum Firmicutes is composed of Clostridium spp. (two). The inappropriate use of antimicrobials initiates a process of dysregulation of the microbiome, called dysbiosis, and it is from the selection of genera and species of bacteria that will dominate the intestine that pseudomembranous colitis can set in with an increased burden of Clostridioides difficile, a gram positive, anaerobic, spore-forming, that produces two enterotoxins, toxin A and toxin.
Currently, pseudomembranous colitis has few treatment options: the main one is fidaxomicin, unavailable in Brazil, and other alternatives are vancomycin and metronidazole. However, refractoriness to alternative treatments may occur, with fecal transplantation also being an alternative. Additionally, fecal transplantation is often associated with better outcomes than drug alternatives, reaching more than 90% clinical success.
Fecal microbiota transplantation (FMT) can occur through different routes, for example, via nasoenteral tube, colonoscopy, oral capsules or enemas, with colonoscopy or capsules normally being apparently more effective than enemas and nasoenteral tubes. Furthermore, the preparation of stool samples can be either fresh or frozen, which do not influence the effectiveness of the treatment. Since 2020, the PUCPR Fecal Microbiota Bank has been carrying out validation studies of a product, PROMICROBIOMA, composed of freeze-dried human fecal microbiota, which has already tested its safety in a phase 1 study on consecutive patients in a convenience sample. To evaluate the effectiveness of the product, it is important to carry out a controlled and randomized clinical study comparing it with antimicrobial therapy.
HYPOTHESIS H0 - PROMICROBIOMA is equal to antibiotic treatment in primary or recurrent CDI H1 - PROMICROBIOME is superior to antibiotic treatment in primary or recurrent CDI H2 - PROMICROBIOME is inferior to antibiotic treatment in primary or recurrent CDI
MAIN GOAL
To evaluate the clinical outcome of patients with primary or recurrent CDI using PROMICROBIOMA compared to antimicrobial therapy.
METHODS
Study design
This is a randomized, controlled clinical study of patients with primary or recurrent CDI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Promicrobioma | Experimental | Other: Fecal microbiota transplant (Promicrobioma)MIcrobiote tranplant |
| Antibiotic (metronidazole or vancomycin) | Active comparator | Drug: AntibioticAntibiotic commonly used for treatment of CDI, including oral vancomycin or metronidazol) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 transplant (Promicrobioma)Fecal microbiota transplant with Promicrobioma (freeze-dried isolated microbiota) | Other | Promicrobioma |
| AntibioticAntibiotics for Clostridioides infection (oral vancomycin) or association of intravenous metronidazol for severe cases. | Drug | Antibiotic (metronidazole or vancomycin) |
Primary outcome
Clinical cure rate
Time frame: 8 weeks
Clinical cure is defined as absence of diarrhea, abdominal pain, clinical signs of infection (fever).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal microbiota transplant (Promicrobioma) and Antibiotic in people with Clostridium Difficile Infections, run by Hospital Universitario Evangelico de Curitiba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Clinical cure rate (time frame: 8 weeks). 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 29 Feb 2024.