The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

Overview

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

Full Title of Study: “The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis – A Case Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2017

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.

Interventions

  • Other: Fecal Microbiota Transplantation Capsules
    • 25 daily multi-donor FMT Capsules for 50 days

Arms, Groups and Cohorts

  • Experimental: FMT treated patients
    • Seven patients with active Ulcerative Colitis treated with 25 multi-donor FMT Capsules daily.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alice Højer Christensen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Alice Højer Christensen, Principal Investigator, MD, Ph.d., Senior Specialist in Medical Gastroenterology – Aleris-Hamlet Hospitaler København
  • Overall Official(s)
    • Alice H Christensen, MD, PhD, Principal Investigator, Aleris-Hamlet Hospitals Copenhagen

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