NCT03082287

Brief Summary

The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the assay outcomes of the ALPCO Calprotectin ELISA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
424

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration 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

First Submitted

Initial submission to the registry

March 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

2.5 years

First QC Date

March 6, 2017

Last Update Submit

November 4, 2019

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • In vitro diagnostic value of Calprotectin

    Value of calprotectin measurement in the ELISA

    Through study completion, up to 52 weeks.

Study Arms (4)

IBD

Adult subjects diagnosed with IBD via endoscopy and histological findings.

Device: Fecal Calprotectin Level

IBS

Adult subjects with IBS as per the Rome IV criteria.

Device: Fecal Calprotectin Level

Other GI Disorders

Adult subjects with gastrointestinal disorders not meeting the Rome IV criteria or IBD diagnosis.

Device: Fecal Calprotectin Level

Healthy Subjects

Adult subjects without any gastrointestinal complaints.

Device: Fecal Calprotectin Level

Interventions

Fecal Calprotectin LevelDEVICE

Measurement of calprotectin in feces

Healthy SubjectsIBDIBSOther GI Disorders

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals that presents with symptoms of IBS/IBD and otherwise healthy subjects

You may qualify if:

  • \>18 years of age
  • Patient must present with signs and symptoms of IBS or IBD
  • Patient must be scheduled for a colonoscopy
  • All results of the colonoscopy including histology must be provided to study site and sponsor.
  • Medical Chart review may be required to confirm diagnosis of IBS or IBD
  • Patient must not have taken NSAIDs for at least 2 weeks prior to participating in the study. Patients may be advised of the study and if report taking NSAIDS may be enrolled in the study after the patient has stopped use of NSAIDS for a minimum of 2 weeks.
  • For normal patient population - study participants must present with no signs or symptoms of IBS or IBD, must not have taken NSAIDs for at least a period of 2 weeks and must be willing to provide a stool sample.
  • Sample must be collected at least 2-3 days prior to colonoscopy
  • Male or female, ≥18 years of age.
  • No abdominal complaints and no history of IBS, IBD, or other chronic intestinal disorder, confirmed by medical history and physical examination at enrollment.
  • May have undergone colonoscopy with negative findings within the past 1 month or may have no recent colonoscopy, but scheduled for routine screening colonoscopy.
  • Able to understand the study and the task required, and sign the ICF.

You may not qualify if:

  • patient under the age of 18
  • Patient taking NSAIDs
  • Patients not presenting with signs or symptoms of IBS or IBD with the exception of 100 normal patients to be included in the study. Fifty (50) presenting for routine colonoscopy and 50 patients presenting with no disease symptoms and not scheduled for a colonoscopy.
  • Patients not scheduled to have an colonoscopy unless enrolled in the study as normal population
  • Unable or unwilling to provide a stool specimen.
  • Have taken protein pump inhibitors (PPIs) or H2-receptor antagonists for control of upper GI disease within the previous 2 weeks.
  • Have taken NSAIDs (including aspirin) on within 2 weeks of study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ALPCO

Salem, New Hampshire, 03079, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool

MeSH Terms

Conditions

Inflammatory Bowel DiseasesIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases, FunctionalColonic Diseases

Study Officials

  • Fran White

    MDC Associates

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 17, 2017

Study Start

May 1, 2017

Primary Completion

October 25, 2019

Study Completion

October 25, 2019

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)