Gut microbiome engraftment during FMT in rCDI, UC, and metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will examine how the gut microbiome engrafts after fecal microbiota transplantation and how this engraftment relates to clinical outcomes across three conditions. The study uses multi-omics analyses to identify microbial taxa, viruses, and host factors that predict engraftment and response. Participants include adults with UC, MetS, or rCDI who meet standard eligibility and receive FMT as part of their care. The goal is to uncover patterns that could guide more effective, personalized microbiome therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Catholic University of the Sacred Heart
  Rome, Rm, Italy Recruiting

Study contacts

• Study coordinator: Gianluca Ianiro, MD, PhD
• Email: gianluca.ianiro@unicatt.it
• Phone: 0630159539

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MGT-006 safety and dosing study for ulcerative colitis

  This study tests an oral microbiome capsule called MGT-006 to see if it is safe and tolerable in adults with moderately active ulcerative colitis, and whether the gut bacteria engraft after treatment.

  Recruiting at 9 sites Phase 1/2 Metagen Therapeutics, Inc. · Naples, Florida and 11 other locations · NCT07913347

• Effect of a Resistance Exercise Program on IGF-1 Levels in Knee Osteoarthritis

  A structured 8-week resistance exercise program is being tested to see if it changes blood IGF-1 levels and improves knee OA symptoms in adults with knee OA and metabolic traits.

  Recruiting Sisli Hamidiye Etfal Training and Research Hospital · Istanbul, Istanbul · NCT07890155

• PALI-2108 vs placebo for moderate to severe ulcerative colitis

  A phase 2 study to see if PALI-2108 helps people with moderate to severe ulcerative colitis more than a placebo.

  Recruiting at 28 sites Phase 2 Palisade Bio · Sun City, Arizona and 114 other locations · NCT07845487

• Preoperative Carbohydrate Drink Before Bariatric Surgery in Metabolic Syndrome

  This trial tests whether drinking a carbohydrate beverage before bariatric surgery helps speed up recovery of digestion in adults with metabolic syndrome.

  Recruiting First Affiliated Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT07822763

• Nitazoxanide as an add-on therapy for mild-to-moderate ulcerative colitis

  A study tests whether adding nitazoxanide to standard UC treatment helps people with mild-to-moderate ulcerative colitis see more relief.

  Recruiting at 2 sites Phase 2/3 Tanta University · Tanta and 1 other locations · NCT07820046

• Fecal Transplants from Dai vs Han Donors for Ulcerative Colitis

  This study tests whether fecal microbiota transplantation from healthy Dai donors improves symptoms in adults with ulcerative colitis more than transplantation from healthy Han donors.

  Recruiting Phase 2 First Affiliated Hospital of Kunming Medical University · Kunming, Yunnan · NCT07814456

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.