NCT06992453 Multi-omics Dissection of Gut Microbiome Engraftment During FMT
| NCT ID | NCT06992453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Catholic University of the Sacred Heart |
| Condition | Recurrent C. Difficile (rCDI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2029-01-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2026-04-23 with a primary completion date of 2029-01-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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). 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06992453 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent C. Difficile (rCDI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06992453 currently recruiting?
Yes, NCT06992453 is actively recruiting participants. Contact the research team at gianluca.ianiro@unicatt.it for enrollment information.
Where is the NCT06992453 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06992453 clinical trial?
NCT06992453 is sponsored by Catholic University of the Sacred Heart. The trial plans to enroll 90 participants.