UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009832 |
|---|---|
| Receipt number | R000011520 |
| Scientific Title | Effects of two types of prebiotics on the intestinal environment and the antibody titers in patients receiving enteral tube feeding: an open-label, randomised controlled trial |
| Date of disclosure of the study information | 2013/01/25 |
| Last modified on | 2015/07/02 10:12:04 |
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Basic information
Public title
Effects of two types of prebiotics on the intestinal environment and the antibody titers in patients receiving enteral tube feeding: an open-label, randomised controlled trial
Acronym
Effects of two types of prebiotics on the intestinal environment and acquired immunity
Scientific Title
Effects of two types of prebiotics on the intestinal environment and the antibody titers in patients receiving enteral tube feeding: an open-label, randomised controlled trial
Scientific Title:Acronym
Effects of two types of 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 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
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
antibody titers after influenza vaccination
Key secondary outcomes
microflora and stool form consistency 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; patients receiving a standard enteral formula for 10 weeks
Interventions/Control_2
F group; patients receiving BGS, galactooligosaccharides and an acidic enteral formula containing lactic-acid-bacteria-fermented ingredients for 10weeks
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
| 56 | 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 irritable bowel syndrome and inflammatory bowel disease, or patients with immune diseases, and diabetics
2. other patients judged as inappropriate for the study by the physician in charge
Target sample size
23
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
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
Homepage URL
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
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
| 2013 | Year | 01 | Month | 25 | 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
Although there was little difference in the Bifidobacterium count in C group during study period, the Bifidobacterium count in F group increased (about 10-fold).
The enhanced HI antibody titers against A/H1N1 and A/H3N2 were maintained in F group for a longer period compared with C group. The seroprotective rates against A/H3N2 in F group at week 6 after influenza vaccination were significantly higher than those in 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
| 2008 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2009 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 22 | 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=R000011520
