The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
NCT ID: NCT03711006
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
7 participants
INTERVENTIONAL
2017-02-01
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FMT treated patients
Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.
Fecal Microbiota Transplantation Capsules
25 daily multi-donor FMT Capsules for 50 days
Interventions
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Fecal Microbiota Transplantation Capsules
25 daily multi-donor FMT Capsules for 50 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
No
Sponsors
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Alice Højer Christensen
OTHER
Responsible Party
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Alice Højer Christensen
Principal Investigator, MD, Ph.d., Senior Specialist in Medical Gastroenterology
Principal Investigators
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Alice H Christensen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aleris-Hamlet Hospitals Copenhagen
Locations
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Aleris-Hamlet Hospital Copenhagen
Søborg, , Denmark
Countries
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Other Identifiers
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16049117
Identifier Type: -
Identifier Source: org_study_id
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