The Th17/Treg Cells and IL-23/IL-17 Axis and Early Entera... | NCT03385850

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

NCT03385850

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Completed

Last Update Posted

Mar 5, 2019Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Sepsis
Immune System Disorder
Enteral Feeding

Interventions

enteral nutrition

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Dec 14, 2017

First Submission Date that Met QC Criteria

Dec 27, 2017

First Posted Date

Dec 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2019

Last Update Posted Date

Mar 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XiangWang, Director, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
early enteral nutrition	Experimental		Other: enteral nutrition
delayed enteral nutrition	Active Comparator		Other: enteral nutrition

Interventions

Name	Type	Description	Arm Group Labels	Other Names
enteral nutrition	Other	early enteral nutrition group or delayed enteral nutrition group	delayed enteral nutrition early enteral nutrition

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
28-d mortality		28 days

Secondary Outcomes

Measure	Description	Time Frame
immune parameters	serum Th17 and Treg lymphocyte percentages	7 days
immune parameters	IL-23, IL-17, IL-6, IL-10 levels	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiang Wang	The First Affiliated Hospital with Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital		Nanjing	Jiangsu	210000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

There is a plan to make individual participant data (IPD) available to other researchers.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D007154	Immune System Diseases

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004750	Enteral Nutrition

Ancestor Terms

ID	Term
D005248	Feeding Methods
D013812	Therapeutics
D018529	Nutritional Support
D044623	Nutrition Therapy

Browse Leaves

Not provided

Browse Branches

Not provided