NCT01961492

Brief Summary

The purpose of this study is to find out whether a single fecal microbiota transplantation is an effective and safe treatment as an adjunct to standard therapy in patients with ulcerative colitis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

4.2 years

First QC Date

October 9, 2013

Last Update Submit

October 12, 2018

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Activity of ulcerative colitis

    Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.

    Within 1 year after the intervention

Secondary Outcomes (3)

  • Colonic inflammation

    Within 1 year after the intervention

  • Colonic inflammation

    Within 1 year after the intervention

  • Adverse events

    Within 1 year after the intervention

Study Arms (2)

Fecal microbiota transplantation

ACTIVE COMPARATOR

A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment

Other: Fecal microbiota transplantation

Standard medical treatment

NO INTERVENTION

Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.

Interventions

Fecal microbiota transplantationOTHER

A single fecal microbiota transplantation through colonoscope

Fecal microbiota transplantation

Eligibility Criteria

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • active ulcerative colitis (PUCAI 10-64) in whom fecal microbiota transplantation via colonoscope can be performed

You may not qualify if:

  • severe ulcerative colitis (PUCAI \> 65)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Marko Kalliomäki, MD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

FI(1)