Back to resultsThe Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Fecal Microbiota Transplantation
Eligibility Criteria
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.
Sites / Locations
- Aleris-Hamlet Hospital Copenhagen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMT treated patients
Arm Description
Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.
Outcomes
Primary Outcome Measures
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
Simple Colitis Clinical Activity Index (SCCAI)
Secondary Outcome Measures
Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
Alpha diversity (Shannon-index)
Fecal microbiota biodiversity in fecal donors
Alpha diversity (Shannon-index)
Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
Alpha diversity (Shannon-index)
Changes in Fecal Calprotectin in the active treatment period and follow-up period
Fecal Calprotectin
Changes in patient reported quality of life: IBDQ
Inflammatory Bowel Disease Questionnaire (IBDQ)
Full Information
NCT ID
NCT03711006
First Posted
October 10, 2018
Last Updated
October 17, 2018
Sponsor
Alice Højer Christensen
1. Study Identification
Unique Protocol Identification Number
NCT03711006
Brief Title
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
Official Title
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alice Højer Christensen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily for 50 days.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Fecal Microbiota Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT treated patients
Arm Type
Experimental
Arm Description
Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation Capsules
Other Intervention Name(s)
FMT Capsules
Intervention Description
25 daily multi-donor FMT Capsules for 50 days
Primary Outcome Measure Information:
Title
Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI)
Description
Simple Colitis Clinical Activity Index (SCCAI)
Time Frame
Baseline, 2,8,16 and 24 weeks
Secondary Outcome Measure Information:
Title
Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity
Description
Alpha diversity (Shannon-index)
Time Frame
Baseline
Title
Fecal microbiota biodiversity in fecal donors
Description
Alpha diversity (Shannon-index)
Time Frame
At donor inclusion
Title
Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline
Description
Alpha diversity (Shannon-index)
Time Frame
8, 16 and 24 weeks
Title
Changes in Fecal Calprotectin in the active treatment period and follow-up period
Description
Fecal Calprotectin
Time Frame
Baseline, 8,16 and 24 weeks
Title
Changes in patient reported quality of life: IBDQ
Description
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
Baseline, 8, 16 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice H Christensen, MD, PhD
Organizational Affiliation
Aleris-Hamlet Hospitals Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aleris-Hamlet Hospital Copenhagen
City
Søborg
ZIP/Postal Code
2860
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data are available upon request
Learn more about this trial
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
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