Examining gut microbiota changes after fecal microbiota transplantation for recurrent Clostridioides difficile infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral donor fecal capsules for recurrent C. difficile infection

  This study tests whether taking donor fecal (FMT) capsules can prevent further C. difficile recurrences in adults who have already had at least two episodes.

  Recruiting Phase 3 Helsinki University Central Hospital · Helsinki, Uusimaa · NCT07458984

• Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics

  This trial tests whether taking short-course oral vancomycin while you need systemic antibiotics can prevent a recurrence of C. difficile in adults recently treated for CDI.

  Recruiting Phase 2/3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT06979609

• VE303 for preventing recurrent Clostridioides difficile infections

  This study is testing a new treatment called VE303 to see if it can help prevent Clostridioides difficile infections from coming back in people who are at high risk.

  Recruiting at 130 sites Phase 3 Vedanta Biosciences, Inc. · Huntsville, Alabama and 214 other locations · NCT06237452

• Diet and counseling to see how meals affect gut health after CDI

  We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.

  Recruiting University of Michigan · Ann Arbor, Michigan · NCT07613645

• Lyophilized fecal microbiota transplant for adults with active ulcerative colitis

  This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.

  Recruiting Phase 1 University of Alberta · Calgary, Alberta and 1 other locations · NCT07401680

• How antibiotics versus fecal transplants affect recovery from C. difficile infection

  This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.

  Recruiting Umeå University · Umeå · NCT07374094

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.