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The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711006
Recruitment Status : Completed
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Alice Højer Christensen, Aleris-Hamlet Hospitaler København

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Fecal Microbiota Transplantation Capsules Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis - A Case Study
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: FMT treated patients
Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.
 Other: Fecal Microbiota Transplantation Capsules
25 daily multi-donor FMT Capsules for 50 days
Other Name: FMT Capsules


Outcome Measures
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Primary Outcome Measures :
  1. Change in patient colitis symptoms as assessed using the Simple Colitis Clinical Activity Index (SCCAI) [ Time Frame: Baseline, 2,8,16 and 24 weeks ]
    Simple Colitis Clinical Activity Index (SCCAI)


Secondary Outcome Measures :
  1. Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity [ Time Frame: Baseline ]
    Alpha diversity (Shannon-index)

  2. Fecal microbiota biodiversity in fecal donors [ Time Frame: At donor inclusion ]
    Alpha diversity (Shannon-index)

  3. Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline [ Time Frame: 8, 16 and 24 weeks ]
    Alpha diversity (Shannon-index)

  4. Changes in Fecal Calprotectin in the active treatment period and follow-up period [ Time Frame: Baseline, 8,16 and 24 weeks ]
    Fecal Calprotectin

  5. Changes in patient reported quality of life: IBDQ [ Time Frame: Baseline, 8, 16 and 24 weeks ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711006


Locations
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Denmark
Aleris-Hamlet Hospital Copenhagen
Søborg, Denmark, 2860
Sponsors and Collaborators
Alice Højer Christensen
Investigators
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Principal Investigator: Alice H Christensen, MD, PhD Aleris-Hamlet Hospitals Copenhagen
More Information
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Responsible Party: Alice Højer Christensen, Principal Investigator, MD, Ph.d., Senior Specialist in Medical Gastroenterology, Aleris-Hamlet Hospitaler København
ClinicalTrials.gov Identifier: NCT03711006    
Other Study ID Numbers: 16049117
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are available upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice Højer Christensen, Aleris-Hamlet Hospitaler København:
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases