UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044635 |
|---|---|
| Receipt number | R000050984 |
| Scientific Title | Food allergy, mucosa-associated microbiota(MAM), cytokines profiles |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/12/25 16:08:04 |
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Basic information
Public title
Food allergy, mucosa-associated microbiota(MAM), cytokines profiles
Acronym
Food allergy, mucosa-associated microbiota(MAM), cytokines profiles
Scientific Title
Food allergy, mucosa-associated microbiota(MAM), cytokines profiles
Scientific Title:Acronym
Food allergy, mucosa-associated microbiota(MAM), cytokines profiles
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Medicine in general | Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cytokines, mucosa-associated microbiota(MAM) profiles in food allergy
Basic objectives2
Others
Basic objectives -Others
food allergy and microbiota in salvia, fecal samples
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Microbiota and cytokine profiles
Key secondary outcomes
Difference among the samples (saliva, gastric mucosa, colonic mucosa, fecal samples)
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
1) patients who have food allergy, and received gastrointestinal endoscopy exam
2) No severe disease
3) patients obtaining consent
Key exclusion criteria
1) severe risks on gastrointestinal endoscopy exam
2) intestinal stenosis, ileus, perforation, toxic megacolon
3) risks on premedication of colonoscopy
4) pregnancy
5) severe mental illness
6) patients who has antibiotics treatments before the entry.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kawasaki Medical School
Division name
Gastroenteroloy
Zip code
701-0192
Address
Matsushima 577, Kurashiki city, Okayama
TEL
086-462-1111
hmatsumoto0311@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kawasaki Medical School
Division name
Gastroenteroloy
Zip code
701-0192
Address
Matsushima 577, Kurashiki city, Okayama
TEL
086-462-1111
Homepage URL
hmatsumoto0311@gmail.com
Sponsor or person
Institute
Kawasaki Medical School, Division of Gastroenterolgy
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School, Division of Gastroenterolgy
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
Kawasaki Medical School
Address
Matsushima 577, Kurashiki city, Okayama
Tel
086-462-1111
kenkyu-idai1@med.kawasaki-m.ac.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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | 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
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
| 2021 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation of food allergy patients
Management information
Registered date
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050984
