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Study on Correlated Factors of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)

Study on Changes of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03200158
Enrollment
53
Registered
2017-06-27
Start date
2016-01-31
Completion date
2017-04-30
Last updated
2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Related Mucosal Disease

Keywords

Stress related mucosal disease (SRMD), APACHEII score, C-reactive protein, Malondialdehyde (MDA), transforming growth factor (TGF), interleukin (IL)

Brief summary

To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).

Detailed description

38 patients admitted to ICU and 15 healthy volunteers were successively enrolled in this study.The healthy volunteers were treated with endoscopy and biopsy .The 38 patients were treated with bedside gastroscopy and diagnosed with SRMD due to illness. The acute physiology and chronic health evaluation(APACHE)II score were evaluated, malondialdehyde (MDA) as an index of oxygen radical-lipid peroxidation was assessed in the serum. Transforming growth factor(TGF)β1,claudin3, interleukin (IL) 1 and interleukin(IL)10 levels in the gastric mucosa and plasma level of superoxide dismutase(SOD),Ischemic modified albumin(IMA)and C-reactive protein(CRP)were evaluated.

Interventions

OTHEREndoscopy biopsy and blood

Medical operation

Sponsors

Qilu Hospital of Shandong University
CollaboratorOTHER
Xiuli Zuo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Occurrence time: ≤72h. * With complete clinical data. * Patients admitted to ICU were treated with bedside endoscopy and diagnosed with SRMD.

Exclusion criteria

* Primary digestive tract diseases included stomach cancer, gastric ulcer, cirrhosis with esophagus fundus ventricularis varices and esophageal cancer. * Patients were complicated with gastric perforation. * Nonsteroidal anti-inflammatory drugs and antiplatelet agents had been used recently, or with the history of major surgery.

Design outcomes

Primary

MeasureTime frameDescription
Nitric oxide synthasei(iNOS)Month 6Measurement of inducible nitric oxide synthasei(iNOS )in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.
interleukin(IL)1βmonth 4Measurement of interleukin(IL)1β in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test IL1β using ELISA method,or we may omit this step.
interleukin(IL)10Month 5We measure interleukin(IL)10 in gastric mucosa by immunohistochemistry method.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test IL10 using ELISA method,or we may omit this step.
malondialdehyde (MDA)(nmol/mL)Month 1MDA is an index of oxygen radical-lipid peroxidation was assessed in the serum。Thiobarbituric acid (TBA)method was applied for MDA.
superoxide dismutase(SOD)(u/mL)Month 1The activity of superoxide dismutase(SOD) reflects the the antioxidant ,capacity.Pyrogallol substrate method was applied for SOD.
claudin3Month 1Tight junctions (TJs) are the most apical component of the intercellular junctional complexes. TJs consist of occludin, the claudin family of proteins, and junctional adhesion molecule (JAM).Among these TJ molecules, claudins are major integral membrane proteins of TJ strands.Studies have shown that H2O2 can change the number of claudin-3.Previously in vitro experiments have reported that H2O2 increases the permeability of the epithelial monolayer by splitting the cell-tight junction complex structure. In our study,the claudin3 in gastric mucosa was measured by western blot method.
TGFβ1Month 2Measurement of TGFβ1 in gastric mucosa by immunohistochemistry method and microscopic observation.Image-Pro Plus 6.0 software was used to select the same brownish yellow as a uniform standard for determining the positiveness of all photographs. Each photo was analyzed to determine the cumulative cumulative optical density of each photograph.We may collect serm to test TGFβ1 using ELISA method,or we may omit this step.
Acute physiology and chronic health evaluation(APACHE)II scoreMonth 3Acute physiology and chronic health evaluation(APACHE)II score was completed within 24h after admitting, including 12 physiological parameters (each item 0-4 points, total score 0-60 points), age (0-6 points) and chronic disease health status (2-5 points). The total score was 0-71 points. The higher the score, the more severe the illness will be.

Secondary

MeasureTime frameDescription
C-reactive protein(CRP)Month 8Latex immunoturbidimetric method was applied for C-reactive protein(CRP).
Ischemic modified albumin(IMA)(u/ml)Month 7Ischemic modified albumin(IMA) is a candidate marker for assessing myocardial ischemia which has been identified as a marker of oxidative stress in a number of studies.Free cobalt colorimetric method was applied for IMA.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026