Clinical study of Enteral nutrition support in patients with Severe head injury

Effect of early enteral nutrition combined with synbiotics agent on nutrition ,immune status and clinical outcome in severe head injurypatients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000804

Enrollment

Unknown

Registered

2010-01-28

Start date

2009-04-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

severe head injury

Interventions

Group A:The patients in control group started receiving RuiSu (enteral nutrition agent ) Within 24 to 48 hours after injury30kca1/(kg.d).

Group B:The patients in study group started receiving RuiSu 30kca1/(kg.d)and Golden Bifid ((synbiotics agent)6g/d, within 24-48 hours after injury

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Closed head injury; 2. Admission time within 12 hours after injury; 3. Clinical and CT proved to be severe head injury; 4. Admission Glasgow Coma Scale was 6-8, and continued for more than 12 h; 5. Age range 18-60 years old.

Exclusion criteria

Exclusion criteria: 1. History of digestive tract diseases; 2. Hematological disease, diabetes and other endocrine diseases; 3. Severe head injury in patients with abdominal trauma; 4. Cancer, pregnancy and malnutrition in patients

Design outcomes

Primary

Measure	Time frame
fatality rate;	—

Secondary

Measure	Time frame
IgA IgG IgM C3 C4;T-lymphocyte subsets;stool SIgA;IL-6 TNF-a;ICU length of stay;Albumin, transferrin, C-reactive protein;quantitative analysis of intestinal flora;infectious complication;	—

Countries

China

Contacts

Public ContactCaixia Xie

xiecaixia1999@163.com+86 13699093647

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026