Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence

Launched by BENOIT GUERY · Mar 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called fecal microbiota transplantation (FMT) for patients with Clostridioides difficile infection (CDI). CDI can cause severe diarrhea and is often tough to treat. In this trial, researchers want to see if adding FMT after standard antibiotic treatment (like vancomycin or fidaxomicin) is more effective than using antibiotics alone for adults who have had their first episode of CDI or a first recurrence. Participants will first receive antibiotics for 10 days and then, if eligible, may receive FMT in the form of capsules.

To participate, individuals must be at least 18 years old, have documented CDI, and not have had complicated cases or certain other health issues. Participants can expect close monitoring throughout the trial to assess how well the treatment works. It's important for potential participants to understand that they will need to give informed consent and may have to follow specific study procedures. The trial is currently recruiting participants and aims to include a diverse group of adults, regardless of gender.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (≥18 years old) at the time of informed consent
• • 2. Informed consent signature
• 3. Medical record documentation of CDI defined as:
• a. A first CDI episode associated with risks factors for recurrence, defined as: i. No CDI episode within the last 8 weeks ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI test performed according to CDI diagnosis ESCMID guidelines (Annex 20.1), with a mandatory toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea iii. Presenting at least one of the following risks factors for CDI recurrence:
• • age \>65 years-old,
• • hospitalization within the last 3 months,
• • use of proton pump inhibitors (PPI) within the last 3 months,
• • Charlson comorbidity index (CCI) \>2,
• • living in long term facility,
• • healthcare- associated CDI (see definition in section 7),
• • severe CDI episode (see definitions in section 6.1.2),
• • immunocompromised patient (except severely immunocompromised according to definitions in section 7.1),
• • history of prior CDI episode(s) (more than 8 weeks ago). OR b. A first CDI recurrence, defined as: i. Previous episode of treated and cured CDI within the last 8 weeks confirmed by medical record documentation of a clinical picture of CDI combined with a positive microbiological CDI test performed according to CDI diagnosis ESCMID guidelines ii. Current combination of CDI signs and symptoms, confirmed by medical record documentation of microbiological evidence of C. difficile toxin and C. difficile in stools shown by a CDI test performed according to CDI diagnosis ESCMID guidelines (Annex 20.1), with a mandatory toxin A/B EIA positive test and without reasonable evidence of another cause of diarrhea.
• • 4. No multiple episodes (no more than 2 CDI episodes) within 3 last months.
• • 5. Already taking since less than 10 days or will start a course of antibiotics (vancomycin or fidaxomicin) to control recurrent CDI symptoms at the time of screening.
• • 6. Willing and able to have FMT by capsule
• Exclusion Criteria:
• • 1. Complicated CDI (at least one of the following signs or symptoms are present and related to CDI: hypotension requiring vasopressors, intensive care unit admission for a complication of CDI, ileus leading to placement of nasogastric tube, toxic megacolon, colonic perforation, colectomy or colostomy)(2),
• • 2. Prior FMT within 6 months of randomization,
• • 3. Prior colectomy, colostomy, ileostomy, or gastrectomy.
• • 4. Metronidazole already given for the treatment of the current CDI for more than 3 days,
• • 5. Need for continued non-anti-CDI systemic antibiotics,
• • 6. Anticipated indication for antibiotics treatment (for a non-CDI reason) in the next 8 weeks,
• • 7. Other causes of acute or chronic diarrhea beyond CDI,
• • 8. Inflammatory bowel disease,
• • 9. Patients with swallowing disorders, Zenker's diverticulum, gastroparesis, or prior small bowel obstruction,
• • 10. Known hypersensitivity to vancomycin or fidaxomicin,
• • 11. Pregnant/lactating women,
• • 12. Estimated patient's life expectancy of less than 10 weeks,
• • 13. Inability to follow protocol study procedures,
• • 14. Inability to give informed consent,
• • 15. Any condition or medications that will put the participant at greater risk from FMT according to the investigator,
• • 16. Severely immunocompromised
• • 17. No response to anti-CDI antibiotic treatment after at least 5 days of treatment (i.e. no diminution of the daily number of stools at BSS 6-7 compared to first day of treatment or worsening of CDI severity parameters)