UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013593
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email akatu@chojuken.net

Sponsor
Institute Fukushimura Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.