UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013593 |
|---|---|
| Receipt number | R000015883 |
| Scientific Title | Effects of an acidic enteral formula containing two types of prebiotics on the intestinal environment and the antibody titers in enterally fed patients: an open-label, randomized controlled trial |
| Date of disclosure of the study information | 2014/04/14 |
| Last modified on | 2015/07/02 10:15:04 |
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Basic information
Public title
Effects of an acidic enteral formula containing two types of prebiotics on the intestinal environment and the antibody titers in enterally fed patients: an open-label, randomized controlled trial
Acronym
Effects of an acidic enteral formula containing prebiotics on the intestinal environment and acquired immunity
Scientific Title
Effects of an acidic enteral formula containing two types of prebiotics on the intestinal environment and the antibody titers in enterally fed patients: an open-label, randomized controlled trial
Scientific Title:Acronym
Effects of an acidic enteral formula containing prebiotics on the intestinal environment and acquired immunity
Region
| Japan |
Condition
Condition
influenza, diarrhea, constipation
Classification by specialty
| Medicine in general | Gastroenterology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of the acidic enteral formula containing two types of prebiotics, which are Bifidogenic Growth Stimulator (BGS) and galactooligosaccharides, on immunological response after the vaccination and the intestinal environment in the enterally-fed patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
antibody titers after influenza vaccination, fecal microflora and stool form consistency during the study period
Key secondary outcomes
blood cytokine levels during the study period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
C group; enterally fed patients receiving a standard enteral formula over a 14-week intervention period and a 4-week follow-up period
Interventions/Control_2
F group; enterally fed patients receiving an acidic enteral formula containing lactic acid bacteria fermented milk product, BGS and galactooligosaccharides during the 14-week intervention period, and then consuming the standard enteral formula during the 4-week follow-up period
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
| 60 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hospitalized patients receiving enteral feeding in Fukushimura Hospital
Key exclusion criteria
1. patients with gastrointestinal disorders such as diarrhea, diabetes, nephropathy, severe infection, autoimmune disease, immunodeficiency, hepatic failure, and cow's milk allergy or soybean allergy.
2. other patients judged as inappropriate for the study by the physician in charge.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Akatsu |
Organization
Fukushimura Hospital
Division name
Choju Medical Institute
Zip code
Address
19-14 Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL
0532-46-7511
akatu@chojuken.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Akatsu |
Organization
Fukushimura Hospital
Division name
Choju Medical Institute
Zip code
Address
19-14 Aza-Yamanaka, Noyori, Toyohashi, Aichi, Japan
TEL
0532-46-7511
Homepage URL
akatu@chojuken.net
Sponsor or person
Institute
Fukushimura Hospital
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
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
福祉村病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Bifidobacterium counts increased significantly in F group compared with C group.
Few subjects in this study attained seroprotective titers against A/H3N2 and B antigens after influenza vaccination in either group, though the seroprotective rates against A/H1N1 were enhanced. The enhanced HI antibody titers against A/H1N1 were maintained in F group for a longer period compared with C group.
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
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015883
