UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039117
Receipt number R000044611
Scientific Title Effect of the habit of eating Okinawa Mozuku (Cladosiphonokamuranus Tokida) and Helicobacter pylori infection on the absorption of fucoidan
Date of disclosure of the study information 2020/01/12
Last modified on 2020/01/10 09:55:09

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Basic information

Public title

Effect of the habit of eating Okinawa Mozuku (Cladosiphonokamuranus Tokida) and Helicobacter pylori infection on the absorption of fucoidan

Acronym

Relevance of the habit of eating Mozuku and Helicobacter pylori infection to the absorption of fucoidan

Scientific Title

Effect of the habit of eating Okinawa Mozuku (Cladosiphonokamuranus Tokida) and Helicobacter pylori infection on the absorption of fucoidan

Scientific Title:Acronym

Relevance of the habit of eating Mozuku and Helicobacter pylori infection to the absorption of fucoidan

Region

Japan


Condition

Condition

No applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the correlation between the frequency of intake of Okinawa Mozuku and Helicobacter pylori infection

Basic objectives2

Others

Basic objectives -Others

To evaluate the intake frequency and urinary Helicobacter pylori antibody titer of Okinawa Mozuku

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of Okinawan Mozuku intake frequency and antibody titer after infection with Helicobacter pylori

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Applicants who gave the infomed consents in writing after receiving enough explanation on of purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will

Key exclusion criteria

For those who have received eradication therapy for Helicobacter pylori in the past and present

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Takeaki
Middle name
Last name Nagamine

Organization

Takasaki University of Health and Welfare

Division name

Department of Nutrition

Zip code

3700036

Address

200-2, Minamioruimachi asahi, Takasaki, Gunma, Japan

TEL

027-388-8840

Email

nagamine-t@kendai-clinic.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Tomori

Organization

South Product Co., Ltd

Division name

Quality assurance

Zip code

9042234

Address

12-75, Suzaki, Uruma, Okinawa, Japan

TEL

098-982-1272

Homepage URL


Email

m-tomori@south-p.co.jp


Sponsor or person

Institute

South Product Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

South Product Co., Ltd

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

South Product Co.,Ltd

Address

12-75, Suzaki, Uruma, Okinawa, Japan

Tel

098-982-1272

Email

m-tomori@south-p.co.jp


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

2020 Year 01 Month 12 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

259

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

2014 Year 02 Month 04 Day

Date of IRB

2014 Year 02 Month 10 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2020 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A urine sample was collected from 259 subjects living in Japan after ingestion of 3 g of fucoidan derived from Mozuku, and the antibody titer of Helicobacter pylori in urine was measured.
As a result, age (over 40 years) was recognized as a factor contributing to H. pylori antibody positivity.
Furthermore, when compared with those aged 40 years or older who took mozuku at least monthly, those living in Okinawa prefecture had significantly higher negative rates of Helicobacter pylori than those living outside Okinawa prefecture.


Management information

Registered date

2020 Year 01 Month 10 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name