Fecal Filtrate as a Treatment Option of Multiple Recurrent Clostridioides Difficile Infection

Launched by UNIVERSITY OF PECS · Jul 10, 2021

Keywords

ClinConnect Summary

The FILTRATE trial is a study that looks at using a new treatment called fecal filtrate transplantation for people who have recurrent Clostridioides difficile infection (CDI), which is a serious gut infection that can cause severe diarrhea and other complications. This trial aims to see if fecal filtrate transplantation is safe and effective compared to the traditional fecal microbiota transplantation (FMT) method. CDI can be particularly challenging to treat, especially when it keeps coming back, and this study hopes to find a better solution.

To be eligible for this trial, participants must be at least 18 years old and have had multiple episodes of CDI, meaning they’ve experienced at least two previous infections. They should also have symptoms like three or more loose stools each day, along with a positive test for the infection. However, certain individuals won’t be able to participate, such as those who are pregnant, currently receiving antibiotics, or have other serious health conditions. If someone joins the study, they can expect to receive close medical supervision and follow-up visits to monitor their health. This research is important as it could lead to improved treatments for a challenging infection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age ≥18 years
• • multiple recurrent CDI (≥2 previous episodes of CDI)
• • at least 3 or more loose or watery stools (Bristol 5-7) per day
• • a positive Glutamate Dehydrogenase (GDH)-enzyme and positive CDI toxin A and/or B test
• • the patient or the legal guardian sign the written informed consent
• Exclusion Criteria:
• • pregnancy or breastfeeding
• • ongoing antibiotic treatment
• • fulminant CDI
• • previous FMT
• • immunodeficiency
• • need of intensive care
• • requirement for vasoactive drugs
• • other cause of diarrhea
• • inflammatory bowel diseases
• • irritable bowel syndrome
• • life expectancy shorter than 3 months
• • unavailable for follow-up visits