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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035776
Receipt No. 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 2019/08/07

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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
Middle name
Last name Shoji Nakamura
Organization OHAYO DAIRY PRODUCTS CO., LTD.
Division name Fundamental laboratory, Research and development 1, Research and development division
Zip code
Address 565 Kojita, Naka-ku, Okayama-City, Okayama, Japan
TEL 086-279-1238
Email s_nakamura@ohayo-milk.com

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Yuzawa
Organization imeQ RD inc.
Division name Sales department
Zip code
Address 2-14-6, Nishi-Waseda, Shinjyuku, Tokyo, Japan
TEL 03-6225-6222
Homepage URL
Email n-yuzawa@imeqrd.co.jp

Sponsor
Institute imeQ RD inc.
Institute
Department

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
Address
Tel
Email

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
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040751

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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