Recurrent C. Difficile (rCDI)Ulcerative Colitis (UC)Metabolic Syndrome (MetS)
Investigational drug(s) / intervention(s)
Fecal microbiota transplantation (FMT)
Fecal microbiota transplantation (FMT): Patients will receive a first donor FMT by colonoscopy, after a pre-conditioning with vancomycin and neomycin + bacitracin for 3 days, because data from our group show that pre-FMT antibiotics are associated with higher rates of microbial engraftment. Then they will receive two cycles, respectively after 3 and 7 days after colonoscopy - FMT, of frozen donor FMT capsules (15 capsules b.i.d. per 3 days). Patients will always receive feces from the same donor.
Study 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). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Coorte: Patients affected by Ulcerative Colitis
* Age ≥18 years.
* 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.
* 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 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.
Primary outcome measure(s)
Longitudinal Analysis of Host-Microbiome Interactions Driving Microbial Engraftment — 60 months To assess the longitudinal multidomain interactions of host and microbiome variables and their influence on microbial engraftment. Microbiome taxonomic profiling will be performed following the general guidelines and relying on the bioBakery computational environment. The taxonomic profiling and quantification of organisms' relative abundances of all metagenomic samples will be quantified using MetaPhlAn 3.0 (species-level profiling) and StrainPhlAn 3 (strain-level profiling). Metatranscriptomics (MTR), metabolomics (MTB) and metaproteomics (MTP) will be performed in stool samples. Through Multiplex Bead analysis for the assessment of specific cytokine in biopsy samples will be perform, following manufacturer's instructions. Flow cytometry will be also performed in colonic biopsies to identify the specific phenotype of immune cells localized in the mucosal samples.
Trial sites (1)
Facility
City
Region
Status
Catholic University of the Sacred Heart
Rome
RM
More Catholic University of the Sacred Heart trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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