The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Fecal Microbiota Transplantation Capsules

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Søborg, Denmark, 2860
    • Aleris-Hamlet Hospital Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: FMT Capsules

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alice Højer Christensen
• Investigators: Principal Investigator: Alice H Christensen, MD, PhD, Aleris-Hamlet Hospitals Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 16049117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data are available upon request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No