Status:
NOT_YET_RECRUITING
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Recurrent C. Difficile (rCDI)
Ulcerative Colitis (UC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Micr...
Detailed Description
Gut microbiota regulates key functions in humans, i.e. immunity and metabolism, and is a pathogenic pathway of many disorders, including recurrent C. difficile infection (rCDI), ulcerative colitis (UC...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 19 2029
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06992453
Start Date
June 1 2025
End Date
February 19 2029
Last Update
May 28 2025
Active Locations (1)
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1
Catholic University of the Sacred Heart
Rome, RM, Italy, 00168