UMIN-CTR Clinical Trial

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
Last 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
Email	umc-d1@inet.msdf.mod.go.jp

Public contact
1st 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
Email	umc-d1@inet.msdf.mod.go.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039433