UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034875 |
|---|---|
| Receipt number | R000039433 |
| Scientific Title | Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2019/05/16 14:32:01 |
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Basic information
Public title
Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Acronym
Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Scientific Title
Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Scientific Title:Acronym
Effects of Guar Gum Decompostion Producton fecal microbiota and other factors in hyperbaric environment
Region
| Japan |
Condition
Condition
Alteration of fecal microbiota
dysbaric osteonecrosis
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Orthopedics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In past experiment, it was confirmed that the intestinal microbial flora changes under a stress environment of hyperbaric environment.
The experiment results suggested that intestinal environment was deteriorated while effective in the formation of the intestinal immune system.
On the other hand, guar gum decomposition products are recognized as having an effect to improve the intestinal environment.
We observe the alteration of fecal microbiota when ingesting guar gum breakdown products under hyperbaric environment and make it use for future treatment.
Dysbaric osteonecrosis has been reported in deep diving with very low frequency. By observing altrations of bone metabolism markers at hyperbaric environment, we will aim to elucidate the mechanism of decompressive osteonecrosis and to prevent it.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First, we will observe alteration of fecal microbiota (Species) before intake of guar gum and one week after intake of guar guam decomposition products.We investigate alteration of fecal microbiota in 0.7 MPa environmentand and during decompression.
Osteometabolism markers one week after intake of guar guam decomposition products.We will make evaluation of osteometabolism markers in the same way.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects are made to intake guar gum decomposition products from 1 week before exposure to hyperbaric condition(0.7 MPa) to the end of exposure to hyperbaric condition.
Interventions/Control_2
The subjects are exposed to hyperbaric condition(0.7 MPa).
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
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male divers who did not refuse cooperation of research
Key exclusion criteria
People with a serious disease history
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Morihiko |
| Middle name | |
| Last name | Oya |
Organization
Maritime Self-Defense Force Umdersea Medical Centor
Division name
Experimental Department
Zip code
237-0071
Address
Tauraminatomachi, Yokosuka, Kanagawa, Japan
TEL
046-822-3500
umc-d1@inet.msdf.mod.go.jp
Public contact
Name of contact person
| 1st name | Morihiko |
| Middle name | |
| Last name | Oya |
Organization
Maritime Self-Defense Force Umdersea Medical Centor
Division name
Experimental Department
Zip code
237-0071
Address
Tauraminatomachi, Yokosuka, Kanagawa, Japan
TEL
046-822-3500
Homepage URL
umc-d1@inet.msdf.mod.go.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Maritime Self-Defense Force Umdersea Medical Centor
Address
Tauraminatomachi, Yokosuka, Kanagawa, Japan
Tel
046-822-3500
umc-d1@inet.msdf.mod.go.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
| 2019 | Year | 01 | Month | 01 | 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
17
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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 13 | Day |
Last modified on
| 2019 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039433
