UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032526 |
|---|---|
| Receipt number | R000037095 |
| Scientific Title | Clinical study for the safety and efficacy of the hydrogen breath test |
| Date of disclosure of the study information | 2018/05/14 |
| Last modified on | 2023/05/14 16:58:58 |
* 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
Clinical study for the safety and efficacy of the hydrogen breath test
Acronym
The safety and efficacy of the hydrogen breath test
Scientific Title
Clinical study for the safety and efficacy of the hydrogen breath test
Scientific Title:Acronym
The safety and efficacy of the hydrogen breath test
Region
| Japan |
Condition
Condition
Digestive disease, healthy adult
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of the safety and efficacy of the hydrogen breath test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concentration measurement of the breath hydrogen using Gastrolyser
Key secondary outcomes
Changes in the breath hydrogen concentration due to circadian rhythm, lactose consumption, hydrogen inhalation, platinum antitumor agent administration and surgical intervention.
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
Those who are informed to the fullest extent about the purposes and contents of the study, have the ability to give consent, volunteer for participation after having fully understood, and agree to participate in the study writing.
Key exclusion criteria
Patients who reject to participate in this study
Patients whom the investigator considers inappropriate for entry into the trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Kiyama |
Organization
TMG Asaka Medical Center
Division name
Department of Surgery
Zip code
351-0023
Address
1340-1 Mizonuma, Asaka, Saitama
TEL
048-466-2055
kiyama@nms.ac.jp
Public contact
Name of contact person
| 1st name | Teruo |
| Middle name | |
| Last name | Kiyama |
Organization
TMG Asaka Medical Center
Division name
Department of Surgery
Zip code
351-0023
Address
1340-1 Mizonuma, Asaka, Saitama
TEL
048-466-2055
Homepage URL
kiyama@nms.ac.jp
Sponsor or person
Institute
Department of Surgery
TMG Asaka Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery
TMG Asaka Medical Center
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
TMG Asaka Medical Center, Ethics committee
Address
1340-1 Mizonuma, Asaka, Saitama
Tel
048-466-2055
h_haruta@tmg.or.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
TMGあさか医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 14 | 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
149
Results
Redox state was quantified using the breath hydrogen pressure in healthy Japanese subjects (n=149). The median pH2 increased from 4.89 to 5.05 after daily activities, which suggested approximately +5 mV oxidation. The breath pH2-scale may thus be a novel marker of the redox state in humans, which is relevant for many medical and research applications.
Results date posted
| 2021 | Year | 11 | Month | 10 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under submission
Date of the first journal publication of results
Baseline Characteristics
This study was conducted on a total of 149 healthy, non-obese Japanese subjects, comprising 98 women and 51 men, with an average age of 29.8 years.
Participant flow
Measurements were carried out using a portable, hand-held H2 monitor at 8 am as the study baseline. The subjects were then allowed to start their daily activities. Measurements were carried out again at noon (before lunch) to avoid the influence of eating and drinking on the breath test results.
Adverse events
none
Outcome measures
We tested the hypothesis that the oxidation-reduction potential (ORP) is proportional to the negative logarithm of the H2 partial pressure (pH2) in phosphate buffer solution (pH=7.1). To determine whether human redox state can be quantified, pH2 was measured by breath H2 partial pressure in healthy human subjects.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037095
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
