GastroparesisNCT03011151
Protease Activated Receptor-2 and Gastrointestinal Dysfunction in Critical Illness
An observational study of Gastroparesis and Gastrointestinal Disorder, Functional, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Gastroparesis, Gastrointestinal Disorder, Functional, Critical Illness
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing posterior spinal fusion and admitted to the pediatric intensive care unit
Who may be able to join
- 2 years and older
Who cannot join
- Liver dysfunction
- Renal dysfunction
- Pre-diagnosed gastroparesis/ delayed gastric emptying
- Pre-diagnosed gastrointestinal malabsorption
- Contraindication to acetaminophen administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Examining the Role of Protease-activated Receptor 2 Agonists in Gastrointestinal Dysfunction in Pediatric Surgical Critical Illness
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.
Read the detailed description
The investigators in this study aim to examine a plausible mechanism by which gastrointestinal dysfunction, gastric dysmotility and loss of epithelial barrier integrity, occur in critical illness. Specifically, the investigators will examine whether an increase in PAR2 agonist levels, zonulin and serine proteases, are associated with gastric dysmotility and loss of epithelial barrier integrity in critical surgical illness in children. The investigators will examine GI function, gastric motility and epithelial barrier integrity, and PAR2 agonist levels, zonulin and serine protease, in participants before surgery and after surgery. Specifically, children undergoing posterior spinal fusion, a known significant inflammatory trigger, and with planned admissions to the intensive care unit will be enrolled. Gastrointestinal function and PAR2 agonist levels will be tested non-invasively in blood and stool.
- Keywords
- pediatric, critical illness, surgery, gastrointestinal dysfunction, gastric emptying, epithelial barrier, nutrition
- Medical subject headings
- Gastroparesis, Gastrointestinal Diseases, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
PAR2 agonist activity- serum zonulin
PAR2 agonist activity will be measured by serum zonulin levels (ng/mL)
Measured: Immediately pre-operative versus post-operative day 1
PAR2 agonist activity- fecal protease activity
PAR2 agonist activity will be measured by fecal serine protease activity (trypsin units/gm protein)
Measured: Immediately pre-operative versus post-operative day 1
Secondary outcomes (2)
Gastric motility by the acetaminophen absorption test- AUC
Pharmacokinetic parameters of acetaminophen will be used to determined gastric motility including the concentration of acetaminophen at 60 minutes (mcg/mL).
Measured: Immediately pre-operative versus post-operative day 1
Epithelial barrier integrity by serum biomarkers
Epithelial barrier integrity by serum biomarkers, specifically serum zonulin (ng/mL) and lipopolysaccharide binding protein levels (ng/mL).
Measured: Immediately pre-operative versus post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 Aug 2017
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enid Martinez, Boston Children's Hospital
- Investigators
- Enid Martinez, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011151
- Sponsor's protocol ID
- IRB-P00024070
- Status last verified
- Apr 2026
- First submitted
- 2 Jan 2017
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez EE, Zurakowski D, Pereira L, Freire R, Emans JB, Nurko S, Duggan CP, Fasano A, Mehta NM. Interleukin-10 and Zonulin Are Associated With Postoperative Delayed Gastric Emptying in Critically Ill Surgical Pediatric Patients: A Prospective Pilot Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1407-1416. doi: 10.1002/jpen.1874. Epub 2020 Jun 3.
PubMed 32386238Martinez EE, Lan J, Konno T, Miranda-Ribera A, Fiorentino M, Mehta NM, Fasano A. Novel role of zonulin in the pathophysiology of gastro-duodenal transit: a clinical and translational study. Sci Rep. 2021 Nov 17;11(1):22462. doi: 10.1038/s41598-021-01879-y.
PubMed 34789790
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of Protease-activated Receptor 2 Agonists in Gastrointestinal Dysfunction in Pediatric Surgical Critical Illness
- ClinicalTrials.gov ID
- NCT03011151
- Acronym / sponsor ID
- IRB-P00024070
- Keywords
- pediatric, critical illness, surgery, gastrointestinal dysfunction, gastric emptying, epithelial barrier, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators in this study aim to examine a plausible mechanism by which gastrointestinal dysfunction, gastric dysmotility and loss of epithelial barrier integrity, occur in critical illness. Specifically, the investigators will examine whether an increase in PAR2 agonist levels, zonulin and serine proteases, are associated with gastric dysmotility and loss of epithelial barrier integrity in critical surgical illness in children. The investigators will examine GI function, gastric motility and epithelial barrier integrity, and PAR2 agonist levels, zonulin and serine protease, in participants before surgery and after surgery. Specifically, children undergoing posterior spinal fusion, a known significant inflammatory trigger, and with planned admissions to the intensive care unit will be enrolled. Gastrointestinal function and PAR2 agonist levels will be tested non-invasively in blood and stool.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing posterior spinal fusion and admitted to the pediatric intensive care unit
Key inclusion criteria (1 listed)
- 2 years and older
Key exclusion criteria (5 listed)
- Liver dysfunction
- Renal dysfunction
- Pre-diagnosed gastroparesis/ delayed gastric emptying
- Pre-diagnosed gastrointestinal malabsorption
- Contraindication to acetaminophen administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PAR2 agonist activity- serum zonulin
Time frame: Immediately pre-operative versus post-operative day 1
PAR2 agonist activity will be measured by serum zonulin levels (ng/mL)
PAR2 agonist activity- fecal protease activity
Time frame: Immediately pre-operative versus post-operative day 1
PAR2 agonist activity will be measured by fecal serine protease activity (trypsin units/gm protein)
2 secondary outcomes
Gastric motility by the acetaminophen absorption test- AUC
Time frame: Immediately pre-operative versus post-operative day 1
Epithelial barrier integrity by serum biomarkers
Time frame: Immediately pre-operative versus post-operative day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 32386238Martinez EE, Zurakowski D, Pereira L, Freire R, Emans JB, Nurko S, Duggan CP, Fasano A, Mehta NM. Interleukin-10 and Zonulin Are Associated With Postoperative Delayed Gastric Emptying in Critically Ill Surgical Pediatric Patients: A Prospective Pilot Study. JPEN J Parenter Enteral Nutr. 2020 Nov;44(8):1407-1416. doi: 10.1002/jpen.1874. Epub 2020 Jun 3.
- Results publication: PubMed 34789790Martinez EE, Lan J, Konno T, Miranda-Ribera A, Fiorentino M, Mehta NM, Fasano A. Novel role of zonulin in the pathophysiology of gastro-duodenal transit: a clinical and translational study. Sci Rep. 2021 Nov 17;11(1):22462. doi: 10.1038/s41598-021-01879-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enid Martinez, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Gastrointestinal Disorder, Functional, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAR2 agonist activity- serum zonulin (time frame: Immediately pre-operative versus post-operative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03011151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.