UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051991 |
|---|---|
| Receipt number | R000059336 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms |
| Date of disclosure of the study information | 2023/08/26 |
| Last modified on | 2024/10/22 17:16:06 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms
Acronym
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms
Scientific Title:Acronym
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Superiority Trial Investigating the Effects of Probiotics on Perennial Allergic Symptoms
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of probiotic intake on symptom improvement in adults with self-reported perennial allergic symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal and ocular allergy self-reported symptom scores (symptom score, medication score, symptom-medication score)
Key secondary outcomes
Japanese rhinoconjunctivitis quality of life questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 capsule a day) for 8 weeks
Interventions/Control_2
Consumption of the placebo food (1 capsule a day) for 8 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Subjects aged 18 years or older and younger than 65 years.
2. Subjects with self-reported perennial allergic symptoms.
3. Subjects with a positive house dust or mite-specific IgE (Class 1 or higher).
4. Subjects who can give informed consent to participate in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who regularly use or have regularly used anti-allergy medications (including antihistamines, eye drops and nasal drops), excluding those who take or have taken them occasionally.
2. Subjects undergoing treatment for hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine, or metabolic conditions, or those with a significant medical history related to these conditions (except for appendectomy).
3. Subjects with a drug allergy or severe food allergy, or those with a history of such allergies.
4. Subjects who are pregnant, intend to become pregnant during the trial period, or are breastfeeding.
5. Subjects who have participated in other clinical trials for drugs or food within the past month, or plan to participate in another clinical trial after consenting to participate in this trial.
6. Subjects who donated blood or component (200 mL) within the last 1 months.
7. Subjects who donated his blood (400 mL) within the last 3 months.
8. Subjects who donated her blood (400 mL) within the last 4 months.
9. Subjects who being collected in total of his blood (1200 mL) within the last 12 months and in this research.
10. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this research.
11. Subjects deemed unsuitable to participate as per the judgment of the principal investigator or sub-investigator, based on the subject's background, physical findings, medical examination, and physiologic test results.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2023 | Year | 08 | Month | 26 | 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
| 2023 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059336
