NCT03200158|Completed
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)
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Study on Changes of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
Sponsor study identifier
interventional
53
1 country
1
Study Start
January 2016
Actual (reported)Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)To study the changes of barrier and immune function in Stress Related Mucosal Disease (SRMD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Actual (reported)April 2017
Actual (reported)April 2017
Actual (reported)May 9, 2017
Actual (reported)June 27, 2017
Actual (reported)malondialdehyde (MDA)（nmol/mL）
MDA is an index of oxygen radical-lipid peroxidation was assessed in the serum。Thiobarbituric acid （TBA）method was applied for MDA.
Month 1
superoxide dismutase(SOD)(u/mL)
The activity of superoxide dismutase(SOD) reflects the the antioxidant ，capacity.Pyrogallol substrate method was applied for SOD.
Month 1
claudin3
Tight 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.
Month 1
Ischemic modified albumin（IMA）(u/ml)
Month 7
C-reactive protein（CRP）
Month 8
The healthy volunteers were treated with endoscopy biopsy and blood.The patients were treated with bedside endoscopy biopsy and diagnosed with SRMD due to illness，then collect their blood samples.
Medical operation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Xiuli Zuo, PhD
Qilu Hospital of Shandong University
53 participants (actual enrollment reported by the registry).
First Submitted
May 9, 2017
First Posted
June 27, 2017
Study Start
January 2016
Actual (reported)TGFβ1
Measurement 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.
Month 2
Acute physiology and chronic health evaluation（APACHE）II score
Acute 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.
Month 3
interleukin（IL）1β
Measurement 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.
month 4
interleukin（IL）10
We 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.
Month 5
Nitric oxide synthasei（iNOS）
Measurement 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.
Month 6
Contact the study team to confirm eligibility.
Primary Completion
April 2017
Actual (reported)Study Completion
April 2017
Actual (reported)Last Updated
June 27, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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