UMIN-CTR Clinical Trial

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
Email	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
Email	khor_cs@um.edu.my

Sponsor
Institute	University of Malaya
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043742