The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

Study Overview
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Brief Summary
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7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.

Detailed Description
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7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24 weeks.

Official Title
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The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Ulcerative Colitis (UC) SCCAI between 4 and 10 at inclusion On a stable dose of 5-aminosalicylic acid (5-ASA) or without current treatment. Previous treatment with glucocorticoids, thiopurines and/or biological treatment was accepted. Fecal Calprotectin > 250 mg/kg Colonoscopy performed within the last 3 years Capable of writing and speaking Danish Attending regular follow-ups by a specialist in gastroenterology. Exclusion Criteria: Biological treatment within the last four weeks Treatment with antibiotics within 48 hours before intervention Alcohol use above current Danish guidelines (14 units/week for men and 7 units/week for women) Pregnancy or planned pregnancy Active cancer disease Medical treatment of mental disorder Other chronic gastroenterological disorder besides UC, Irritable Bowel Syndrome (IBS) or Reflux-disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Interventional Model Description: The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT treated patients<br>Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily. | Other: Fecal Microbiota Transplantation Capsules<br>* 25 daily multi-donor FMT Capsules for 50 days<br>* Other names: FMT Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI) | Simple Colitis Clinical Activity Index (SCCAI) | Baseline, 2,8,16 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity | Alpha diversity (Shannon-index) | Baseline | 
| Fecal microbiota biodiversity in fecal donors | Alpha diversity (Shannon-index) | At donor inclusion | 
| Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline | Alpha diversity (Shannon-index) | 8, 16 and 24 weeks | 
| Changes in Fecal Calprotectin in the active treatment period and follow-up period | Fecal Calprotectin | Baseline, 8,16 and 24 weeks | 
| Changes in patient reported quality of life: IBDQ | Inflammatory Bowel Disease Questionnaire (IBDQ) | Baseline, 8, 16 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplantation