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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200158
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Qilu Hospital of Shandong University
Information provided by (Responsible Party):
Xiuli Zuo, Shandong University

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

Condition or disease Intervention/treatment Phase
Stress Related Mucosal Disease Other: Endoscopy biopsy and blood Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study on Changes of Barrier and Immune Function in Stress Related Mucosal Disease (SRMD)
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Arm Intervention/treatment
Endoscopy biopsy and blood
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.
Other: Endoscopy biopsy and blood
Medical operation




Primary Outcome Measures :
  1. malondialdehyde (MDA)(nmol/mL) [ Time Frame: Month 1 ]
    MDA is an index of oxygen radical-lipid peroxidation was assessed in the serum。Thiobarbituric acid (TBA)method was applied for MDA.

  2. superoxide dismutase(SOD)(u/mL) [ Time Frame: Month 1 ]
    The activity of superoxide dismutase(SOD) reflects the the antioxidant ,capacity.Pyrogallol substrate method was applied for SOD.

  3. claudin3 [ Time Frame: Month 1 ]
    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.

  4. TGFβ1 [ Time Frame: Month 2 ]
    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.

  5. Acute physiology and chronic health evaluation(APACHE)II score [ Time Frame: Month 3 ]
    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.

  6. interleukin(IL)1β [ Time Frame: month 4 ]
    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.

  7. interleukin(IL)10 [ Time Frame: Month 5 ]
    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.

  8. Nitric oxide synthasei(iNOS) [ Time Frame: Month 6 ]
    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.


Secondary Outcome Measures :
  1. Ischemic modified albumin(IMA)(u/ml) [ Time Frame: Month 7 ]
    Ischemic 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.

  2. C-reactive protein(CRP) [ Time Frame: Month 8 ]
    Latex immunoturbidimetric method was applied for C-reactive protein(CRP).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200158


Locations
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China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Xiuli Zuo
Qilu Hospital of Shandong University
Investigators
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Principal Investigator: Xiuli Zuo, PhD Qilu Hospital of Shandong University
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Responsible Party: Xiuli Zuo, Deputy director of the physician, Shandong University
ClinicalTrials.gov Identifier: NCT03200158    
Other Study ID Numbers: 2015SDU-QILU-G006
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiuli Zuo, Shandong University:
Stress related mucosal disease (SRMD)
APACHEII score
C-reactive protein
Malondialdehyde (MDA)
transforming growth factor (TGF)
interleukin (IL)