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 |
* 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
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
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
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
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
