UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031031 |
|---|---|
| Receipt number | R000035438 |
| Scientific Title | Gut microbiome analysis of multiple chemical sensitivity |
| Date of disclosure of the study information | 2018/01/28 |
| Last modified on | 2023/01/07 11:11:41 |
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Basic information
Public title
Gut microbiome analysis of multiple chemical sensitivity
Acronym
Gut microbiome analysis of multiple chemical sensitivity
Scientific Title
Gut microbiome analysis of multiple chemical sensitivity
Scientific Title:Acronym
Gut microbiome analysis of multiple chemical sensitivity
Region
| Japan |
Condition
Condition
Multiple chemical sensitivity/Idiopathic environmental intorelance
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the differences in gut microbiomes of patients with multiple chemical sensitivity and controls using the analysis based on 16S rRNA gene sequence/metagenomic sequence.
Basic objectives2
Others
Basic objectives -Others
To clarify the differences in gut microbiomes of patients with multiple chemical sensitivity and controls using the analysis based on 16S rRNA gene sequence/metagenomic sequence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The differences in gut microbiomes of patients with multiple chemical sensitivity and controls using the analysis based on 16S rRNA gene sequence/metagenomic sequence
Key secondary outcomes
Association between gut microbiome and environmental factors including hypersensitive chemical substances
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. Female
2. The age at the time of consent acquisition is 19 years old or more
3. Person who meets Multiple Chemical Sensitivity criteria of 1999 consensus and is equivalent to Very suggestive in risk criteria using Japanese Quick Environmental Exposure and Sensitivity Inventory
4. Person who agrees with participation in this research
Key exclusion criteria
1. Comorbid with mastocytoma or porphyria.
2. Only due to psychogenic disorder
3. The patient judged as unsuitable for participation by the researcher
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Watai |
Organization
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name
Department of allergy
Zip code
Address
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
TEL
+81-42-742-8311
k-watai@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Watai |
Organization
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name
Department of allergy
Zip code
Address
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
TEL
042-742-8311
Homepage URL
k-watai@sagamihara-hosp.gr.jp
Sponsor or person
Institute
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Clinical Research Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構相模原病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 28 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
height, weight, gender, onset age, disease duration, the history of chemical exposures, family history,birth history, comorbid disease, QEESI questionnaire, gut microbiome
Management information
Registered date
| 2018 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035438
