Fecal Transplantation in Ulcerative Colitis

Study Overview
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Brief Summary
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Adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (FMT) in colonoscopy. A half of the patients will receive autologous FMT as a placebo and a half will receive an FMT from a healthy donor.

Detailed Description
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80 adult patients with ulcerative colitis (UC) will be recruited. They are randomized to receive either an autologous FMT as a placebo or FMT from a healthy donor (frozen and thawed). The patients are followed up with fecal samples to detect microbial changes. The follow up lasts 1 year after the FMT and a follow up colonoscopy will be done 52 weeks after the FMT.

Official Title
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FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF ULCERATIVE COLITIS

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Fecal microbiota transplantation (FMT)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • • Diagnosis of CU based on clinical, endoscopic, and histological findings. Remission assessed by Mayo score (0 to 1) and F-Calpro (<100 ug/g). Availability of consecutive fecal samples during one year after the diagnosis of CU. Availability of blood sample to study the IBD associated genetic background Compliance to attend ileocolonoscopy and FMT within 3-6 months after the diagnosis of CU and at 52 week 18-75 years Exclusion Criteria: Unable to provide informed consent Need for any antibiotic therapy within 3 months Use of corticosteroids, immunosuppressive or biological medication at the baseline Use of any probiotics Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized in two groups to receive in colonoscopy either a fecal suspension made of their own feces or a fecal suspension of a healthy donor.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FMT<br>50% of the participants will receive fecal suspension of a healthy donor administered in colonoscopy into the cecum | Other: Fecal microbiota transplantation (FMT)<br>* FMT administered into the cecum of the patient in colonoscopy.<br>|
| Placebo Comparator: Placebo<br>50% of the participants will receive fecal suspension made of their own feces administered in colonoscopy into the cecum. | Other: Placebo<br>* Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of remission of ulcerative colitis | Endoscopic remission and Mayo-score < 2 | 52 weeks |