Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

NCT06107569 | Not Yet Recruiting Phase 3

• 1 other identifier: CDItransplant
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Clostridium Difficile Infections

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate

  Clinical cure is defined as absence of diarrhea, abdominal pain, clinical signs of infection (fever).

  8 weeks

Study Arms (2)

Promicrobioma

EXPERIMENTAL

MIcrobiote tranplant

Other: Fecal microbiota transplant (Promicrobioma)

Antibiotic (metronidazole or vancomycin)

ACTIVE COMPARATOR

Antibiotic commonly used for treatment of CDI, including oral vancomycin or metronidazol)

Drug: Antibiotic

Interventions

Fecal microbiota transplant (Promicrobioma) OTHER

Fecal microbiota transplant with Promicrobioma (freeze-dried isolated microbiota)

Promicrobioma

Antibiotic DRUG

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

Antibiotic (metronidazole or vancomycin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant patients
• Severe form of CDI requiring surgery
• Impossibility of performing the colonoscopy procedure or using a nasoenteral tube

Sponsors & Collaborators

• Hospital Universitario Evangelico de Curitiba: lead

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fecal Microbiota Transplantation; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 30, 2023
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 29, 2024

Record last verified: 2024-02