Superdonor FMT in Patients With Ulcerative Colitis

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special type of fecal microbiota transplantation (FMT) from healthy donors, called "super-donor FMT," can help patients with Ulcerative Colitis (UC). FMT helps restore the balance of good bacteria in the gut and has shown success in treating other conditions, like severe Clostridioides difficile infections. Researchers want to see if using a super-donor, who has specific health and lifestyle traits that promote a healthy gut microbiome, will be more effective for UC patients compared to standard treatment.

To be eligible for this trial, participants should be adults aged 18 to 75 with mild to moderate UC, diagnosed within the last year, and currently stable on maintenance medication for their condition. Participants will receive either super-donor FMT or a placebo (a treatment that looks the same but has no active ingredients) through a colonoscopy and capsules, followed by regular check-ins for two months. This study aims to gather important data on how well super-donor FMT works for people with UC, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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