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New treatment option for Active Ulcerative Colitis
Official title Superdonor FMT in Patients With Ulcerative Colitis
ClinicalTrials.gov ID: NCT05739864
What this study is testing
What is FMT?
FMT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for active ulcerative colitis.
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
- In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 between 18 and 75 years old
- Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\> 4 weeks with...
- Recent diagnosis (\< 12 months) of Ulcerative Colitis;
- Ability to provide written informed consent
- Ability to be compliant with the scheduled procedures
You likely can't join if
- Age \< 18 years old
- Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic...
- Previous colorectal surgery or cutaneous stoma
- Current or recent (\< 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors...
- Decompensated heart failure or heart disease with ejection fraction lower than 30%
- Severe respiratory insufficiency
See the full eligibility criteria
- Age between 18 and 75 years old
- Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\> 4 weeks with Aminosalicylates, \> 6 weeks with immunosuppressant or biologics agents);
- Recent diagnosis (\< 12 months) of Ulcerative Colitis;
- Ability to provide written informed consent
- Ability to be compliant with the scheduled procedures
- Age \< 18 years old
- Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)
- Previous colorectal surgery or cutaneous stoma
- Current or recent (\< 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors or metformin)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, Lazio, 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.