Multi-omics Dissection of Gut Microbiome Engraftment During FMT

Launched by CATHOLIC UNIVERSITY OF THE SACRED HEART · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the gut microbiome, which is the collection of bacteria and other microorganisms in our intestines, affects the success of fecal microbiota transplantation (FMT) in treating conditions like recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). FMT has shown great promise for rCDI, with about 90% of patients seeing improvement, but its effectiveness in chronic conditions can vary. Researchers want to understand what factors help the gut microbiome take hold after FMT and how this relates to patient recovery.

To participate in this trial, you must be at least 18 years old and have one of the targeted conditions. For example, people with active UC who have not received certain treatments or those with metabolic syndrome must meet specific health criteria. If eligible, participants can expect to contribute to important research that may help improve treatment for these conditions. It’s important to note that women who are pregnant or breastfeeding cannot participate, and there are some other health conditions that might exclude you from joining. Overall, this study aims to provide valuable insights into how the gut microbiome influences treatment outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Coorte: Patients affected by Ulcerative Colitis
• • Age ≥18 years.
• • Biologic-naïve active UC
• • UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)
• • UC during stable maintenance therapy (\> 8 weeks with salicylates, immunosuppressants);
• • Ability to give informed consent.
• • Coorte: Patients affected by metabolic syndrome
• • Age ≥18 years.
• • Patients with MetS (high glycaemia levels (\> 100 mg/dL), hypertension (\> 130/85 mmHg), raised triglyceride levels (\> 150 mg/dL), low high-density lipoprotein cholesterol levels (\< 40 mg/dL in men; \<50 mg/dL in women), and abdominal obesity (waist circumference of \> 102 cm in men; \>88 cm in women)
• • Stable treatment (\> 8 weeks) of one of these disorders, included in MetS definition.
• • Family history of diabetes mellitus type 2
• • Polycystic ovary syndrome (PCOs)
• • Ability to give informed consent
• • Coorte: Patients affected by rCDI
• • Age ≥18 years
• • Mild recurrent Clostridioides difficile infection (26)
• • Ability to give informed consent.
• • Exclusion criteria
• • Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).
• • Known active gastrointestinal disorders (e.g. infectious gastroenteritis except CDI, coeliac disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) apart from UC, with clinical characteristics reports in inclusion criteria.
• • Antimicrobial treatment or use of probiotics up to 4 weeks prior to screening visit (apart for patients with rCDI)
• • Previous colorectal surgery or cutaneous stoma
• • Critical and severe comorbidities
• • Inability to give informed consent.