The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

Alice Højer Christensen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ulcerative Colitis

Treatments

Other: Fecal Microbiota Transplantation Capsules

Study type

Interventional

Funder types

Other

Identifiers

NCT03711006

16049117

Details and patient eligibility

About

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

Full 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.

Enrollment

7 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.