NCT02768038

Brief Summary

The aim is to examine the role of intestinal microbiota in the pathogenesis of chronic inflammatory bowel diseases (IBD)

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 May 2016

Longer than P75 for all trials

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withdrawn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

First Submitted

Initial submission to the registry

December 16, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

4.6 years

First QC Date

December 16, 2015

Last Update Submit

April 28, 2025

Conditions

Colitis

Outcome Measures

Primary Outcomes (1)

  • Change of microbiome in chronic inflammatory bowel disease

    5 yrs

Interventions

ObservationalOTHER

Blood, stool ja biopsy specimens

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with IBD living at the Turku University Hospital area

You may qualify if:

  • IBD

You may not qualify if:

  • patient refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20521, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and stool specimens. Biopsy specimens from large intestine ja ileum.

MeSH Terms

Conditions

Colitis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Markku Voutilainen, Prof.

    Head, Department of Gastroenterology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

May 11, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)