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The Th9/IL-9 and Early Enteral Nutrition in Sepsis

The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03791866
Enrollment
60
Registered
2019-01-03
Start date
2018-10-01
Completion date
2020-06-30
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Nutrition, Intestinal Mucosal Barrier, Sepsis, Th9 Cells

Brief summary

The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. 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. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.

Interventions

OTHERNutrition

Enteral nutrition

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
28-d mortality28 days

Secondary

MeasureTime frameDescription
Serum Th9 lymphocyte percentages7 daysSerum Th9 lymphocyte percentages
Concentration of serum IL-97 daysConcentration of serum IL-9
Concentration of serum iFABP7 daysConcentration of serum iFABP
Concentration of serum DAO7 daysConcentration of serum DAO

Countries

China

Contacts

Primary ContactJie Zhou
565219791@qq.com+8613913893984

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026