Fecal Microbiota Transplantation in Patients With Ulcerative Colitis

Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01961492

Enrollment

Registered

2013-10-11

Start date

2013-10-31

Completion date

2018-12-31

Last updated

2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

OTHERFecal microbiota transplantation

A single fecal microbiota transplantation through colonoscope

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* severe ulcerative colitis (PUCAI \> 65)

Design outcomes

Primary

Measure	Time frame	Description
Activity of ulcerative colitis	Within 1 year after the intervention	Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.

Secondary

Measure	Time frame	Description
Colonic inflammation	Within 1 year after the intervention	Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
Adverse events	Within 1 year after the intervention	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026