Intestinal Microbiome and Chronic Inflammatory Bowel Disease | NCT02768038

Studies
Intestinal Microbiome and Chronic Inflammatory Bowel Disease

NCT02768038

Sponsor

Turku University Hospital

Status

Withdrawn

Last Update Posted

May 1, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Colitis

Interventions

Observational

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The researcher (Ph student) interrupted the dissertation project

Expanded Access Info

Start Date

May 1, 2016Estimated

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2025

Last Update Posted Date

May 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

IBD patients to whom colonoscopy is performed will be recruited. Mucosal specimens from large intestine and terminal ileum will be collected as well as stool specimens. The microbiota will be analyzed at the microbiology laboratory and the results will be correlated with endoscopical, laboratory and histopathological findings.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Blood, stool ja biopsy specimens

Measure	Description	Time Frame
Change of microbiome in chronic inflammatory bowel disease		5 yrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Exclusion Criteria:

patient refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with IBD living at the Turku University Hospital area

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markku Voutilainen, Prof.	Head, Department of Gastroenterology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital		Turku		20521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003092	Colitis

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D003108	Colonic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided