UCRecruiting

FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach

Phase 1 / Phase 2 · Testing single FMT and sequential FMT · 1 site · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing single FMT (a biologic) and sequential FMT (a biologic) as a possible treatment. Condition(s) listed: Clostridium Difficile and Ulcerative Colitis.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

Ages 18 to 75
Any sex

Some of the main requirements, copied from the record:

Age ≥18 years;
Active UC (partial Mayo score ≥2);
Relapsing infection of C. difficile;

Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 64 participants are expected to take part.
Start date: 2023-09-23.
Main results expected around 2026-09-24 (estimate from the record).
1 study site listed (1 marked recruiting) in Italy.

Main thing being measured

Number of UC patients who will obtain the eradication of rCDI 8 weeks after treatments (single FMT vs sequential FMT) (2 months)

In the researchers’ words

Clostridioides difficile infection (CDI) is the most frequent cause of infectious diarrhea in hospitalized patients and is responsible for 20-30 % of antibiotic-associated diarrhea cases. Inflammatory bowel diseases (IBD) are associated with an higher prevalence, recurrence and severity of CDI.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Phase 1 / Phase 2
Study type	Interventional
Conditions	Clostridium Difficile; Ulcerative Colitis
Lead sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment	64 (estimated)
Start date	2023-09-23
Primary completion (est.)	2026-09-24
First posted	2023-10-06
Last updated	2026-03-19
Official title	Fecal Microbiota Transplantation in Patients With Recurrent Clostridioides Cifficile Infection and Ulcerative Colitis: Single Infusion Versus Sequential Approach
ClinicalTrials.gov ID	NCT06071312

Interventions

single FMT (Biological)
This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through a single infusion of FMT
sequential FMT (Biological)
This intervention is represented by the administration, in the recipients' gut, of healthy donor microbiota through multiple infusions of FMT (sequential approach)

Full eligibility criteria (from the record)

Inclusion Criteria:

* Age ≥18 years;
* Active UC (partial Mayo score ≥2);
* Relapsing infection of C. difficile;
* Ability to express consent for inclusion in the study.
* Indication, in the clinical practice setting, for fecal microbiota transplantation from a healthy donor for recurrent CDI

Exclusion Criteria:

* Age < 18 years;
* Other gastrointestinal infections, excluding C. difficile;
* Known gastrointestinal diseases, other than UC, in active stage (e.g., infectious gastroenteritis, celiac disease, irritable bowel syndrome, chronic pancreatitis, bile acid diarrhea, etc.);
* Previous colon surgery or skin ostomy packing;
* Food allergies;
* Current or recent (<2 weeks) therapy with drugs that may alter the microbiota (e.g., systemic antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin), except antibiotics against C. difficile;
* Heart failure or heart disease with FE ≤ 30 %;
* Severe respiratory failure;
* Psychiatric disorders;
* Pregnancy and lactation;
* Inability to provide informed consent.

Locations (1)

Site	City	Country	Site status
Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS	Rome	Italy	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.