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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024879
Receipt No. R000028631
Scientific Title The effect of gastric secretion on lower intestinal microflora.
Date of disclosure of the study information 2016/11/17
Last modified on 2016/11/17

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Basic information
Public title The effect of gastric secretion on lower intestinal microflora.
Acronym The effect of gastric secretion on lower intestinal microflora.
Scientific Title The effect of gastric secretion on lower intestinal microflora.
Scientific Title:Acronym The effect of gastric secretion on lower intestinal microflora.
Region
Japan

Condition
Condition healthy stomoach, atrophic gastritis
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigete the Improvement effect of Japanese apricot on lower intestinal microflora and serum cytokine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes lower intestinal microflora , serum cytokine, serum triglyceride and serum cholesterol value
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Healthy stomoach, atrophic gastritis
Key exclusion criteria a person with a history of the gastrectomyand Hp erradication, a person who takes PPI and H2 receptor blocker
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Maekita
Organization School of Medicine, Wakayama Medical University
Division name Department of Gastroenterology
Zip code
Address 811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL 073-447-2300
Email maekita@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Maekita
Organization School of Medicine, Wakayama Medical University
Division name Department of Gastroenterology
Zip code
Address 811-1 Kimiidera, Wakayama, Wakayama 641-0012, Japan
TEL 073-447-2300
Homepage URL
Email maekita@wakayama-med.ac.jp

Sponsor
Institute School of Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization School of Medicine, Wakayama Medical University
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 17 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
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 Open public recruiting
Date of protocol fixation
2010 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participants included individuals who receive specific medical check-ups by the local community health service and have a medical examination in Wakayama Medical University Hospital. Helicobacter Pyloti-related gastritis are examined using a serum PG test and anti-Helicobacter IgG antibody.Subjects are divided into Four groups according to progress of atrophy.Investigate lower intestinal microflora in four groups.

Management information
Registered date
2016 Year 11 Month 17 Day
Last modified on
2016 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028631

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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