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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.

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. - A study for the effect of microorganism containing foods on infectious diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038386
Enrollment
374
Registered
2019-10-25
Start date
2019-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None (Healthy adults)

Interventions

Microorganism containing food (tablet form), once a day for 12 weeks Microorganism not containing food (tablet form), once a day for 12 weeks

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
- Incident rate of specific infectious diseases - Severity of symptoms of specific infectious diseases - Antibody titers against specific virus in blood

Secondary

MeasureTime frame
- Specific virus titers in blood - Incident rate of ful-like illness - Severity of symptoms of ful-like illness

Countries

Asia(except Japan)

Contacts

Public ContactKhor Chee Sieng

University of Malaya Tropical Infectious Diseases Research and Education Center

khor_cs@um.edu.my+603-79676670

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026