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


Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name