NCT06992453Recruiting

Multi-omics Dissection of Gut Microbiome Engraftment During FMT

Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 90 (estimated)
First submitted: 13 May 2025
Start date: 23 Apr 2026
Primary completion date: 19 Jan 2029
Lead sponsor: Catholic University of the Sacred Heart
Diseases: Ulcerative colitis
NCT number: NCT06992453

What you commit to

Study type: Interventional
Planned participants: 90
From 23 Apr 2026 to the primary completion date, 19 Jan 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI)
Previous colorectal surgery or cutaneous stoma

Other illness

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.

Other

Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).
Critical and severe comorbidities
Inability to give informed consent.

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Catholic University of the Sacred Heart Coordinator of this site? Confirm its status	Rome	Italy	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.