Treatment of CDI and Recurrence With Fecal Microbiota Transplant Using Promicrobioma

Launched by HOSPITAL UNIVERSITARIO EVANGELICO DE CURITIBA · Oct 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for patients with Clostridium difficile infections (CDI), which can cause severe diarrhea and other intestinal problems. The researchers want to see if a treatment called fecal microbiota transplant (FMT) using a product called Promicrobioma can help patients recover from CDI and prevent it from coming back. FMT involves transferring healthy bacteria from a donor's stool into the patient's intestines to restore the balance of good bacteria that can be disrupted by antibiotics.

To participate in this trial, you need to be over 18 years old and currently hospitalized with a confirmed CDI diagnosis. If you have had CDI before and it has come back within the last eight weeks after treatment, you may also be eligible. However, pregnant individuals and those with severe CDI that requires surgery cannot take part. If you join the trial, you will receive the FMT treatment and be monitored closely to see how well it works. It's important to know that this trial is not yet recruiting participants, but it aims to help improve treatment options for those suffering from CDI.

Gender

ALL

Eligibility 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