UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045595 |
|---|---|
| Receipt number | R000052052 |
| Scientific Title | Study on the effect of functional barley intake on the gut microbiota in children with allergic diseases |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2025/04/02 20:00:58 |
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Basic information
Public title
Study on the effect of functional barley intake on the gut microbiota in children with allergic diseases
Acronym
Study on the effect of functional barley intake on the gut microbiota in children with allergic diseases
Scientific Title
Study on the effect of functional barley intake on the gut microbiota in children with allergic diseases
Scientific Title:Acronym
Study on the effect of functional barley intake on the gut microbiota in children with allergic diseases
Region
| Japan |
Condition
Condition
Egg allergy or atopic dermatitis
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal whether comsuming functional barley increases the proportion of butyric acid producing bacteria in children with allergic diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in proportion of butyric acid producing bacteria in the gut microbiota
Key secondary outcomes
Fecal butyric acid concentration
Ratio of Tregs in peripheral lymphocyte
Serum IgE, Specific IgE
Bacterial composition
EASI score, POEM score
TARC
Threshold of egg allergy trigger
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food: Cookies containing functional barley
Duration: 16 weeks
Dose:6g (1-3 years) or 9g (over 4 years) of functional barley
Intervention frequence: Once daily
Interventions/Control_2
Test food: Cookies containing rice flour
Duration: 16 weeks
Dose: 6g (1-3 years) or 9g (over 4 years) of rice flour
Intervention frequence: Once daily
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
| 1 | years-old | <= |
Age-upper limit
| 8 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children diagnosed as egg allergy or atopic dermatitis by physicians and agreed to join the study.
Key exclusion criteria
Children with food allergy other than eggs or children who was prescribed antibiotics in the last three months.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
5731010
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
+81728040101
akagawas@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University
Division name
Department of Pediatrics
Zip code
5731010
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
+81728040101
Homepage URL
akagawas@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Self supply
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
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
+81 728042440
rinriirb@hirakata.kmu.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
関西医科大学附属病院（大阪府）
近畿大学病院（大阪府）
八尾市立病院（大阪府）
大阪はびきの医療センター（大阪府）
市立貝塚病院（大阪府）
国保中央病院（奈良県）
住友病院（大阪府）
神戸市立医療センター西市民病院（兵庫県）
大和高田市立病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052052
