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Completed

NCT Number: NCT03385850

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

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

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Key information

Conditions

Sepsis Enteral Feeding Immune System Diseases Immune System Disorder Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of sepsis
  • Within 3 days of sepsis onset before ICU admission
  • No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission

Exclusion criteria

  • Ileus
  • Digestive tract hemorrhage
  • Inflammatory bowel disease
  • Abdominal hypertension (IAP >25mmHg)
  • Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
  • Malnutrition or immunodeficiency
  • Long-term use of hormones

Treatment and study plan

Enteral nutrition

Other

early enteral nutrition group or delayed enteral nutrition group

Primary outcomes

  1. 28-d mortality

    Time frame: 28 days

Secondary outcomes

  1. immune parameters

    Time frame: 7 days

    serum Th17 and Treg lymphocyte percentages

  2. immune parameters

    Time frame: 7 days

    IL-23, IL-17, IL-6, IL-10 levels

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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