Status:

RECRUITING

Changes in Recipients Gut Microbiota After Fecal Microbiota Transplantation

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Clostridioides Difficile Infection Recurrence

Eligibility:

All Genders

18-90 years

Brief Summary

Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overal...

Detailed Description

Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea, and the most common health care-associated infectious disease in the United States, accounting for 15% of overal...

Eligibility Criteria

Inclusion Criteria:

  • Recurrent Clostridioides difficile infection
  • Age between 18 and 90 years old
  • Ability to provide written informed consent
  • Ability to be compliant with the scheduled procedures

Exclusion Criteria:

  • Another known gastrointestinal infection apart from C. difficile infection

    . Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)

  • Previous colorectal surgery or cutaneous stoma

  • Current or recent (< 6 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics)

  • Decompensated heart failure or heart disease with ejection fraction lower than 30%

  • Severe respiratory insufficiency

  • Psychiatric disorders

  • Pregnancy or breastfeeding

  • Unable to give informed consent

Key Trial Info

Start Date :

February 13 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 14 2027

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05739825

Start Date

February 13 2023

End Date

February 14 2027

Last Update

March 19 2026

Active Locations (1)

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1

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy