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

NCT03200158 | Completed

• 1 other identifier: 2015SDU-QILU-G006
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Related Mucosal Disease

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Ischemic modified albumin（IMA）(u/ml)

  Month 7

• C-reactive protein（CRP）

  Month 8

Study Arms (1)

Endoscopy biopsy and blood

OTHER

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

Interventions

Endoscopy biopsy and blood OTHER

Medical operation

Endoscopy biopsy and blood

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiuli Zuo: lead
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xiuli Zuo, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director of the physician

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 27, 2017
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 27, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)