NCT00863694

Brief Summary

Elevated fecal calprotectin is a biomarker for intestinal inflammation in cystic fibrosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

4.5 years

First QC Date

March 16, 2009

Last Update Submit

December 12, 2013

Conditions

Cystic Fibrosis

Keywords

cystic fibrosiscalprotectinelastase

Outcome Measures

Primary Outcomes (1)

  • collection of 150 stool specimens

    2 years

Eligibility Criteria

Age1 Month+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending the cystic fibrosis clinics at the Children's Hospital of Wisconsin and Froedtert Hospital

You may qualify if:

  • All patients

You may not qualify if:

  • Informed consent/assent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Steven Werlin, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatric Gastroenterology, M.D.

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 18, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

US(1)