UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038386 |
|---|---|
| Receipt number | R000043742 |
| Scientific Title | A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial. |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2022/04/21 16:15:24 |
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Basic information
Public title
A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Acronym
A study for the effect of microorganism containing foods on infectious diseases
Scientific Title
A study for the effect of microorganism containing foods on incident rate of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.
Scientific Title:Acronym
A study for the effect of microorganism containing foods on infectious diseases
Region
| Asia(except Japan) |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of microorganism containing foods on incident rate of infectious diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Incident rate of specific infectious diseases
- Severity of symptoms of specific infectious diseases
- Antibody titers against specific virus in blood
Key secondary outcomes
- Specific virus titers in blood
- Incident rate of ful-like illness
- Severity of symptoms of ful-like illness
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
Microorganism containing food (tablet form), once a day for 12 weeks
Interventions/Control_2
Microorganism not containing food (tablet form), once a day for 12 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Provide signed and dated informed consent form
(2) Willingness to comply with all study procedures for the duration of the study
(3) Malaysia citizen
(4) Aged more than 18 years old (adult)
(5) Residing at specific communities
(6) Not feeling sick with fever for the past 2 weeks in the preliminary screening
(7) No underlying diseases or sickness in the preliminary screening
(8) Individuals tested negative for anti-virus antibodies in the preliminary blood test
Key exclusion criteria
(1) Unable to provide signed and dated informed consent form
(2) Unable to comply with all the study procedures
(3) Below legal age (aged < 18 years old)
(4) Unable to identify biological gender
(5) Not Malaysian citizen
(6) Allergic to fermented food products
(7) Take steroid regularly (e.g. for allergies)
(8) Consume foods, drinks or supplements containing probiotic on regular basis
(9) Women who are pregnant, or intend to get pregnant during the study period, or breastfeeding mothers
(10) Planned to go overseas for more than two weeks in total all over the study time.
(11) Participate in other tests with the intake of food and pharmaceutical products
(12) With the history suffering from digestive diseases or operation experience of the digestive tracts to affect the digestion and absorption
(13) Are positive for specific anti-viral antibodies or viral antigens (HBV, HCV, HIV, or HTLV-1) in inspection of the pre-intervention blood sample
(14) Cannot stop drinking alcohol for two days before drawing blood
(15) Persons determined as not appropriate based on the blood biochemistry test results
(16) Additionally, other persons whom the principal investigator or sub-investigator deems inappropriate as participants for the study
Target sample size
374
Research contact person
Name of lead principal investigator
| 1st name | Sazaly |
| Middle name | |
| Last name | AbuBakar |
Organization
University of Malaya
Division name
Tropical Infectious Diseases Research and Education Center
Zip code
50603
Address
Administration Office, High Impact Research Building, Level 2, Universiti Malaya, 50603 Kuala Lumpur
TEL
+603-79676670
sazaly@um.edu.my
Public contact
Name of contact person
| 1st name | Khor |
| Middle name | |
| Last name | Chee Sieng |
Organization
University of Malaya
Division name
Tropical Infectious Diseases Research and Education Center
Zip code
50603
Address
Administration Office, High Impact Research Building, Level 2, Universiti Malaya, 50603 Kuala Lumpur
TEL
+603-79676670
Homepage URL
khor_cs@um.edu.my
Sponsor or person
Institute
University of Malaya
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings 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
University of Malaya Medical Centre, Medical Research Ethics Committee
Address
Pusat Perubatan Universiti Malaya,Lembah Pantai, 59100, Kuala Lumpur, MALAYSIA
Tel
+603-79494422
ummc@ummc.edu.my
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
University of Malaya Medical Centre (Kuala Lumpur)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/13/12/4507
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/13/12/4507
Number of participants that the trial has enrolled
320
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 | 08 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043742
