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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001326
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Morinaga Milk Industry Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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