The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711006
• Other study ID #: 16049117
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2018
• Source: Aleris-Hamlet Hospitaler København
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Denmark	Aleris-Hamlet Hospital Copenhagen	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Alice Højer Christensen

Country where clinical trial is conducted

Denmark, 

Outcome

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