UMIN-CTR Clinical Trial

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
Institute	South Product Co., Ltd
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044611