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A prospective, multicenter, randomized, controlled trial to evaluate the tolerance and protection function of (TPF-FOS) JEVITY on the gastrointestinal tract in critical ill patients

A prospective, multicenter, randomized, controlled trial to evaluate the tolerance and protection function of (TPF-FOS) JEVITY on the gastrointestinal tract in critical ill patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002334
Enrollment
Unknown
Registered
2012-06-25
Start date
2012-06-03
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

critical ill patients(APACHE ?scores>12points)

Interventions

A:feeding Ensure
B:feeding JEVITY

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 years old; 2. The APACHE II score > 12 points; 3. Have enteral nutrition indications and is expected to take enteral nutrition >=5 days; 4. Have signed the information consent form.

Exclusion criteria

Exclusion criteria: 1. severe hemodynamic instability; 2. Have the enteral nutrition contraindications (active gastrointestinal hemorrhage, ileus,abdominal compartment syndrome (ACS), acute pancreatitis, acute stage of inflammatory bowel disease, etc); 3 .White blood cells < 10^9/L; 4. Be allergic to any ingredient of the products; 5. Have participated in another researchIn within 2 months before the start of the study; 6. Whom the researchers thought not suitable for the study; 7. Whom be reluctant to sign the information consent form or follow the research plan.

Design outcomes

Primary

MeasureTime frame
the rate of gastrointestinal adverse reaction;Laboratory examinations(blood routine, liver and kidney function,blood lipid level, CRP);fat granule at each high magnification field of vision;

Secondary

MeasureTime frame
D-lactic acid level in blood;intestinal fatty acid binding protein level in the blood;Clostridium difficile toxins in the stool;Coccus: bacillus proportion in the stool;

Countries

China

Contacts

Public ContactBin Ouyang
binouyang@yahoo.com+86 13501549273

Outcome results

None listed

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