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A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients

A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients - Effects of immunonutrition in tube-fed patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001326
Enrollment
126
Registered
2008-09-01
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

malnutrition

Interventions

Enteral formula with lactoferrin and nucleic acids (immune-enhancing enteral formula) Enteral formula without lactoferrin and nucleic acids

Sponsors

Morinaga Milk Industry Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with serum albumin level between 2.5 and 3.5 g/dL. 2) Patients whose nutrition has come completely from enteral feeding for at least one month. 3) Patients who are expected to continue enteral feeding during the study period. 4) Patients with life expectancy of at least 6 months.

Exclusion criteria

Exclusion criteria: 1) Patients with co-morbid diseases which might affect evaluation of study, such as infectious disease. 2) Patients on artificial dialysis. 3) Patients allergic to milk, soybeans, wheat, or fish oil. 4) Patients participating in other clinical trials. 5) Patients who are judged inappropriate for the study by the physician.

Design outcomes

Primary

MeasureTime frame
Natural killer cell activity, phagocytic and sterilizing activity of neutrophils, high sensitive C-reactive protein, albumin, prealbumin

Secondary

MeasureTime frame
Body weight, fever from infectious disease, arm circumference, triceps skinfold thickness, calf circumference

Countries

Japan

Contacts

Public ContactYoshiaki Takeuchi

Showa University, School of Medicine Department of Gastroenterology

03-3784-8535

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026