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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 March 2025 |
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Main ID: |
NCT05739864 |
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Date of registration:
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13/02/2023 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Superdonor FMT in Patients With Ulcerative Colitis
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Scientific title:
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Evaluation of the Efficacy of Superdonor Fecal Microbiota Transplantation in Patients With Mild-to-moderate Ulcerative Colitis: a Double-blind Randomized Controlled Trial |
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Date of first enrolment:
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February 13, 2023 |
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Target sample size:
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42 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05739864 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Gianluca Ianiro, MD, Phd |
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Address:
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Telephone:
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+39 0630157338 |
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Email:
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gianluca.ianiro@unicatt.it |
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Affiliation:
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Name:
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Gianluca Ianiro, MD |
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Address:
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Telephone:
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+39 0630157338 |
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Email:
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gianluca.ianiro@unicatt.it |
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Affiliation:
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Name:
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Gianluca Ianiro |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondazione Policlinico Universitario A. Gemelli, IRCCS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Active Ulcerative Colitis
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Intervention(s)
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Biological: FMT
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Other: Placebo FMT
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Primary Outcome(s)
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Number of patients who will obtain remission of disease 8 weeks after treatments
[Time Frame: 2 months]
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Secondary Outcome(s)
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Number of patients who will obtain clinical response
[Time Frame: 2 months]
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Number of patients who will obtain endoscopic remission 1,4 and 8 weeks after treatments
[Time Frame: 2 months]
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Evaluation of changes in recipients' microbiome after treatments, at each time point.
[Time Frame: 2 months]
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Evaluation of changes in serum cytokines after treatments, at each time point.
[Time Frame: 2 months]
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Number of patients who will obtain clinical disease remission 1,4 and 8 weeks after treatments.
[Time Frame: 2 months]
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Number of patients who will obtain remission of disease 1 and 4 weeks after treatments.
[Time Frame: 1 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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