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Completed

NCT Number: NCT03711006

The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Aleris-Hamlet Hospital Copenhagen

Søborg, 2860, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fecal Microbiota Transplantation Capsules

Other

25 daily multi-donor FMT Capsules for 50 days

Other names: FMT Capsules

Primary outcomes

  1. 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 outcomes

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

    Time frame: Baseline

    Alpha diversity (Shannon-index)

  2. Fecal microbiota biodiversity in fecal donors

    Time frame: At donor inclusion

    Alpha diversity (Shannon-index)

  3. 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)

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

    Time frame: Baseline, 8,16 and 24 weeks

    Fecal Calprotectin

  5. Changes in patient reported quality of life: IBDQ

    Time frame: Baseline, 8, 16 and 24 weeks

    Inflammatory Bowel Disease Questionnaire (IBDQ)

Sponsors and collaborators

Lead sponsor

Alice Højer Christensen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 18, 2018
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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