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NCT03011151
Protease Activated Receptor-2 and Gastrointestinal Dysfunction in Critical Illness
trial in Gastroparesis in 99 participants. Completed in 30 June 2024.
30 June 2024
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 99 |
| Start date | 1 August 2017 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across United States |
Conditions studied
- Gastroparesis — all drugs for Gastroparesis →
- Gastrointestinal Disorder, Functional — all drugs for Gastrointestinal Disorder, Functional →
- Critical Illness — all drugs for Critical Illness →
Sponsor
Boston Children's Hospital
Who can join
Adults 2 to 30, any sex, with Gastroparesis or Gastrointestinal Disorder, Functional. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier integrity, is associated with significant morbidity in critical illness. The mechanisms underlying GI dysfunction in critical illness are not well understood. GI dysfunction in surgery and critical illness has been associated with inflammation. There is evidence to suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically GI serine proteases and zonulin, released under conditions of inflammation. In this study the investigators will examine the relationship between inflammation and PAR2 activation by PAR2 agonists and subsequent GI dysfunction in pediatric critically ill surgical patients. The overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine proteases and zonulin, released due to inflammation results in gastric dysmotility and loss of epithelial barrier integrity. In this study, the investigators will examine whether PAR2 agonist expression is increased and correlates with GI dysfunction in critically ill surgical pediatric patients. This proposal fills a knowledge gap in the understanding of mechanisms for GI dysfunction in critical illness, and will be applicable to all surgical and medical critically ill children.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Protease-Activated Receptors - Key Regulators of Inflammatory Bowel Diseases Progression.
Jacenik D, Fichna J, Małecka-Wojciesko E, Mokrowiecka A. · · 2021 · cited 7× · PMID 35002281 · DOI 10.2147/jir.s335502
Verify or expand the search:
- PubMed search for NCT03011151
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastroparesis
Currently open trials in the same condition.
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- NCT07526935 — Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator · NA · active not recruiting
- NCT05981300 — GpCRC Pediatric Gastroparesis Registry 2 · recruiting
- NCT06580197 — The Role of AAT After Abdominal Surgery Based on RWS · recruiting
Other Boston Children's Hospital trials
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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 NCT03011151 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
- Last refreshed: 17 April 2026
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/NCT03011151.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing