Superdonor FMT in Patients With Ulcerative Colitis

NCT05739864 | Recruiting Phase 1

• 1 other identifier: 5184
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice. Recently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P\<0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI. Nowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor. In addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%). Currently, studies that explored the efficacy of the super-donor FMT in UC patients are not yet available. Aim of this study is to investigate the efficacy of super - donor FMT, compared with placebo FMT, in the treatment of UC. The investigators will randomize adult patients with a recent diagnosis of UC to FMT from super - donors or placebo, by colonoscopy (first infusion) and capsules administration. Then, patients will be followed up 2 months after FMT.

Conditions

Active Ulcerative Colitis

Keywords

Ulcerative Colitis; Fecal Microbiota Trasplantation; Super - donor

Outcome Measures

Primary Outcomes (1)

• Number of patients who will obtain remission of disease 8 weeks after treatments

  The investigators will evaluate evaluate the number of participants who will obtain disease remission (assessed by total mayo score \</= 2, or endoscopic Mayo \</= 1) 8 weeks after treatments.

  2 months

Secondary Outcomes (6)

• Number of patients who will obtain remission of disease 1 and 4 weeks after treatments.

  1 months

• Number of patients who will obtain clinical disease remission 1,4 and 8 weeks after treatments.

  2 months

• Number of patients who will obtain endoscopic remission 1,4 and 8 weeks after treatments

  2 months

• Number of patients who will obtain clinical response

  2 months

• Evaluation of changes in recipients' microbiome after treatments, at each time point.

  2 months

Study Arms (2)

Donor FMT (D-FMT)

EXPERIMENTAL

Patients enrolled in this arm will receive donor FMT

Biological: FMT

Placebo FMT (P - FMT)

PLACEBO COMPARATOR

Patients enrolled in this arm will receive placebo FMT

Other: Placebo FMT

Interventions

FMT BIOLOGICAL

This intervention is represented by the administration, in the recipients' gut, of super - donor microbiota through FMT

Donor FMT (D-FMT)

Placebo FMT OTHER

This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT

Placebo FMT (P - FMT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years old
• Mild to Moderate Ulcerative Colitis (total Mayo score 3 -10 + endoscopic subscore ≥ 1) in stable maintenance therapies (\> 4 weeks with Aminosalicylates, \> 6 weeks with immunosuppressant or biologics agents);
• Recent diagnosis (\< 12 months) of Ulcerative Colitis;
• Ability to provide written informed consent
• Ability to be compliant with the scheduled procedures

You may not qualify if:

• Age \< 18 years old
• Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, Crohn disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea)
• Previous colorectal surgery or cutaneous stoma
• Current or recent (\< 2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors or metformin)
• Decompensated heart failure or heart disease with ejection fraction lower than 30%
• Severe respiratory insufficiency
• Psychiatric disorders
• Pregnancy or breastfeeding
• Unable to give informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Gianluca Ianiro

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Gianluca Ianiro

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Ianiro, MD

CONTACT

+39 0630157338; gianluca.ianiro@unicatt.it

Serena Porcari, MD

CONTACT

+39 0630157338; porcariserena89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To mask treatments to physicisans and recipients, both FMT flasks and syringes will be covered with dark-coloured paper before the infusion, and the patients will be unable to see the endoscopic display during the procedure. Super - donor capsules or placebo ones will look the same. Moreover, the physicians who will evsaluate patients at follow-up will not aware of the treatment being administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: placebo-controlled, double blind randomized clinical trial

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: February 13, 2023
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 14, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available after the completion of the study, for 5 years
• Access Criteria: Data will be given upon request to the PI

Locations

IT (1)