Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

Clostridium Difficile Infections Clinical Trial

Official title:

Randomized Controlled Clinical Study of Treatment of Clostridioides Difficile Infection Comparing Fecal Microbiota Transplantation With Antibiotic Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06107569
• Other study ID #: CDItransplant
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Hospital Universitario Evangelico de Curitiba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: January 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infections
• Clostridium Infections
• Infections

Intervention

Other:
• Fecal microbiota transplant (Promicrobioma)
Fecal microbiota transplant with Promicrobioma (freeze-dried isolated microbiota)

Drug:
• Antibiotic
Antibiotics for Clostridioides infection (oral vancomycin) or association of intravenous metronidazol for severe cases.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Evangelico de Curitiba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate	Clinical cure is defined as absence of diarrhea, abdominal pain, clinical signs of infection (fever).	8 weeks