UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001326 |
|---|---|
| Receipt number | R000001612 |
| Scientific Title | A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2010/08/23 07:58:20 |
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Basic information
Public title
A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients
Acronym
Effects of immunonutrition in tube-fed patients
Scientific Title
A randomized controlled trial of immune-enhancing enteral feeding on immunologic and nutritional status in tube-fed patients
Scientific Title:Acronym
Effects of immunonutrition in tube-fed patients
Region
| Japan |
Condition
Condition
malnutrition
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of long-term intake of immune-enhancing enteral formula on immunologic and nutritional status in tube-fed patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Natural killer cell activity, phagocytic and sterilizing activity of neutrophils, high sensitive C-reactive protein, albumin, prealbumin
Key secondary outcomes
Body weight, fever from infectious disease, arm circumference, triceps skinfold thickness, calf circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Enteral formula with lactoferrin and nucleic acids (immune-enhancing enteral formula)
Interventions/Control_2
Enteral formula without lactoferrin and nucleic acids
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
126
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Takeuchi |
Organization
Showa University, School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8535
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Takeuchi |
Organization
Showa University, School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8535
Homepage URL
Sponsor or person
Institute
Morinaga Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 20 | Day |
Last modified on
| 2010 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001612
