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Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

H

Hospital Universitario Evangelico de Curitiba

Status and phase

Not yet enrolling
Phase 3

Conditions

Clostridium Difficile Infections

Treatments

Other: Fecal microbiota transplant (Promicrobioma)
Drug: Antibiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT06107569
CDItransplant

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria are:

  1. Over 18 years old;
  2. Hospitalized patients;
  3. Clinical and laboratory diagnosis of CDI;
  4. Signing the informed consent form
  5. 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:

  1. Pregnant patients
  2. Severe form of CDI requiring surgery
  3. Impossibility of performing the colonoscopy procedure or using a nasoenteral tube

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Promicrobioma
Experimental group
Description:
MIcrobiote tranplant
Treatment:
Other: Fecal microbiota transplant (Promicrobioma)
Antibiotic (metronidazole or vancomycin)
Active Comparator group
Description:
Antibiotic commonly used for treatment of CDI, including oral vancomycin or metronidazol)
Treatment:
Drug: Antibiotic

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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