The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

NCT03711006 | Completed Phase 1

• 1 other identifier: 16049117
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fecal microbiota biodiversity in patients with Ulcerative Colitis and difference to donors fecal microbiota diversity

  Baseline

• Fecal microbiota biodiversity in fecal donors

  At donor inclusion

• Changes in fecal microbiota biodiversity in patients with Ulcerative Colitis in comparison with value at baseline

  8, 16 and 24 weeks

• Changes in Fecal Calprotectin in the active treatment period and follow-up period

  Baseline, 8,16 and 24 weeks

• Changes in patient reported quality of life: IBDQ

  Baseline, 8, 16 and 24 weeks

Study Arms (1)

FMT treated patients

EXPERIMENTAL

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

Other: Fecal Microbiota Transplantation Capsules

Interventions

Fecal Microbiota Transplantation Capsules OTHER

25 daily multi-donor FMT Capsules for 50 days

Also known as: FMT Capsules

FMT treated patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with Ulcerative Colitis (UC)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alice Højer Christensen: lead

Study Sites (1)

Aleris-Hamlet Hospital Copenhagen

Søborg, 2860, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Alice H Christensen, MD, PhD

  Aleris-Hamlet Hospitals Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, Ph.d., Senior Specialist in Medical Gastroenterology

Model Details: 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

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 18, 2018
• Study Start: February 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: October 18, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)