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NCT03082287
ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
trial testing Fecal Calprotectin Level in Inflammatory Bowel Diseases in 424 participants. Completed in 25 October 2019.
25 October 2019
Quick facts
| Lead sponsor | American Laboratory Products Company |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 424 |
| Start date | 1 May 2017 |
| Primary completion | 25 October 2019 |
| Estimated completion | 25 October 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Fecal Calprotectin Level
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Irritable Bowel Syndrome — all drugs for Irritable Bowel Syndrome →
Sponsor
American Laboratory Products Company
Who can join
22 and older, any sex, with Inflammatory Bowel Diseases or Irritable Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03082287
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other American Laboratory Products Company trials
Trials by the same sponsor.
- NCT06810518 — ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03082287 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by American Laboratory Products Company
- Last refreshed: 5 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03082287.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing