UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035776 |
|---|---|
| Receipt number | R000040751 |
| Scientific Title | A study to examine the effects of Lactobacillus salivarius L55 intake on relief from eye and nasal discomfort. |
| Date of disclosure of the study information | 2019/02/15 |
| Last modified on | 2021/02/16 19:22:04 |
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Basic information
Public title
A study to examine the effects of Lactobacillus salivarius L55 intake on relief from eye and nasal discomfort.
Acronym
A study to examine the effects of Lactobacillus salivarius L55 intake on relief from eye and nasal discomfort.
Scientific Title
A study to examine the effects of Lactobacillus salivarius L55 intake on relief from eye and nasal discomfort.
Scientific Title:Acronym
A study to examine the effects of Lactobacillus salivarius L55 intake on relief from eye and nasal discomfort.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of test food for eye and nasal discomfort after 12-week ingestion of test food in healthy Japanese males and females (20 to 64 years old) who do not need drug treatment but complain of eye and nasal discomfort (such as sneezing, a blocked or runny nose, and itchy eyes) in their everyday lives.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eye and nasal symptom questionnaire ,The Japanese Rhinoconjunctivitis Quality of Life Questionnaire version 2002 (JRQLQ No1)
Key secondary outcomes
Assessment of the nasal cavity (mucosal swelling and mucosal color of the inferior turbinate, serous fluid volume, and characteristics of nasal discharge)
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
Drink fermented milk containing only Lactobacillus salivarius L55 once daily after a meal.
Interventions/Control_2
Drink placebo once daily after a meal.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 to 64 years old (at the time of submission of an informed consent document).
2. Japanese males and females.
3. Those who have symptoms, such as itchy eyes and a blocked or runny nose, in their everyday lives, but those who are healthy and have no chronic somatic disorders.
4. Body mass index (BMI) of less than 30 kg/m2
5. Non-smokers (which include electronic cigarette users)
6. Those who can collaborate on 12-week ingestion of test food.
7. Those who have a device available for an electronic diary and who can input their own data into the device.
8. Those who receive a full explanation of the purpose and content of this clinical trial, those who desire and voluntarily request to participate in this clinical trial with a full understanding of its explanation, those who have the capability to consent, and those who can give their written informed consent.
9. Those who were judged as non-diseased individuals by the principal investigator or a sub-investigator and those who were determined to be suitable for participation in this clinical trial.
Key exclusion criteria
1. Those who were categized into "severe" or "the most severe" according to the classification of allergic rhinitis based on severity of symptoms.
2. Those who have acute rhinitis, sinusitis, nasal polyp, hypertrophic rhinitis, and deviated septum.
3. Those who have bronchial asthma as a complication.
4. Those who have the serious disorders of the liver, heart, kidney, respiratory system, endocrine, and metabolism.
5. Those who currently receive or have previously received allergen immunotherapy.
6. Those who currently take some kind of medication for therapeutic purposes.
7. Those with a past and current medical history of drug or food allergy.
8. Those who ingest Lactobacillus preparations, Lactobacillus supplements, yogurts, foods for specified health use, and foods with function claims on a daily basis (however, at the time of submission of an informed consent document, those who can stop ingesting foods listed above during the study period are excluded).
9. Those who are currently pregnant or breastfeeding or those who desire a pregnancy during the study period.
10. Those who have experienced a feeling sick or health deterioration due to blood sampling.
11. Those who have diarrhea by dairy products and those who have lactose intolerance.
12. Those who participated in another clinical trial within one month before our screening test and those who took an active ingredient provided in the clinical trial.
13. Those who may undergo lifestyle changes (such as a long trip) during the study period.
14. Those who were determined by the principal investigator to be unsuitable for participation in this clinical trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Nakamura |
Organization
OHAYO DAIRY PRODUCTS CO., LTD.
Division name
Fundamental laboratory, Research and development 1, Research and development division
Zip code
703-8225
Address
565 Kojita, Naka-ku, Okayama-City, Okayama, Japan
TEL
086-279-1238
s_nakamura@ohayo-milk.com
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
OHAYO DAIRY PRODUCTS CO., LTD.
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2019 | Year | 02 | Month | 15 | 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
| 2019 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040751
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