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NCT03385850 Clinical Trial

The Th17/Treg Cells and IL-23/IL-17 Axis and Early Enteral Nutrition in Sepsis

Sepsis Clinical Trial

Official title:
The Roles of Th17/Treg Cells and IL-23/IL-17 Axis in the Mechanisms of Early Enteral Nutrition Improving Immune Function of Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03385850
Other study ID # NanjingFirst
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date December 31, 2018

Study information
Verified date March 2019
Source Nanjing First Hospital, Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aim to evaluate the roles of Th17/Treg cells and IL-23/IL-17 axis in the mechanisms of early enteral nutrition (EEN) correcting immune imbalance of sepsis by means of improving the intestinal flora disturbance. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date December 31, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Clinical diagnosis of sepsis

2. Within 3 days of sepsis onset before ICU admission

3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion Criteria:

1. Ileus

2. Digestive tract hemorrhage

3. Inflammatory bowel disease

4. Abdominal hypertension (IAP >25mmHg)

5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)

6. Malnutrition or immunodeficiency

7. Long-term use of hormones

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• enteral nutrition
early enteral nutrition group or delayed enteral nutrition group

Locations
Country Name City State
China Nanjing First Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 28-d mortality 28 days
Secondary immune parameters serum Th17 and Treg lymphocyte percentages 7 days
Secondary immune parameters IL-23, IL-17, IL-6, IL-10 levels 7 days
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