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)

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

Study Overview

• Status: Completed
• Conditions: Stress Related Mucosal Disease
• Intervention / Treatment: Other: Endoscopy biopsy and blood

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic modified albumin（IMA）(u/ml)	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.	Month 7
C-reactive protein（CRP）	Latex immunoturbidimetric method was applied for C-reactive protein（CRP）.	Month 8

Collaborators and Investigators

• Sponsor: Xiuli Zuo
• Collaborators: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: C-reactive protein; interleukin (IL); Malondialdehyde (MDA); Stress related mucosal disease (SRMD); APACHEII score; transforming growth factor (TGF)
• Other Study ID Numbers: 2015SDU-QILU-G006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No