Examining gut microbiota changes after fecal microbiota transplantation for recurrent Clostridioides difficile infection
Assessment Of Changes In Gut Microbiota Of Patients With Recurrent Clostridioides Difficile Infection After Fecal Microbiota Transplantation: Prospective Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05739825
This study is testing how a fecal transplant from healthy donors affects the gut bacteria of people with recurring Clostridioides difficile infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT05739825 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with recurrent Clostridioides difficile infection (rCDI) and aims to evaluate the changes in gut microbiota following fecal microbiota transplantation (FMT) from healthy donors. The study will utilize metagenomics analysis to assess microbial diversity and understand the mechanisms behind the clinical efficacy of FMT. Participants will be monitored for their response to the treatment and any changes in their gut microbiota composition. The findings could provide insights into the effectiveness of FMT as a treatment option for rCDI.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 who have recurrent Clostridioides difficile infections and can provide informed consent.
Not a fit: Patients with other gastrointestinal infections, severe comorbidities, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment options for patients suffering from recurrent Clostridioides difficile infections, potentially reducing recurrence rates and associated complications.
How similar studies have performed: Previous studies have shown that fecal microbiota transplantation is an effective treatment for recurrent Clostridioides difficile infections, supporting the potential success of this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Gianluca Ianiro — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Gianluca Ianiro, MD, PhD
- Email: gianluca.ianiro@unicatt.it
- Phone: +390630157338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clostridioides Difficile Infection Recurrence, Clostridioides difficile infection, Fecal Microbiota Trasplantation, Engraftment