BridgeMD
Compares treatment options for Clostridium Difficile
Official title FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
ClinicalTrials.gov ID: NCT06071312
What this study is testing
What is single FMT?
single FMT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clostridium difficile.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age ≥18 years;
- Active UC (partial Mayo score ≥2);
- Relapsing infection of C. difficile;
- Ability to express consent for inclusion in the study.
- Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI
You likely can't join if
- Age \< 18 years;
- Other gastrointestinal infections, excluding C. difficile;
- Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic...
- Previous colon surgery or skin ostomy packing;
- Food allergies;
- Current or recent (\<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors...
See the full eligibility criteria
- Age ≥18 years;
- Active UC (partial Mayo score ≥2);
- Relapsing infection of C. difficile;
- Ability to express consent for inclusion in the study.
- Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI
- Age \< 18 years;
- Other gastrointestinal infections, excluding C. difficile;
- Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.);
- Previous colon surgery or skin ostomy packing;
- Food allergies;
- Current or recent (\<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile;
- Heart failure or heart disease with FE ≤ 30 %;
- Severe respiratory failure;
- Psychiatric disorders;
- Pregnancy and lactation;
- Inability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.