A human trial to Fermented soybean(Cheonggukjang powder) on intestinal microflora and immunity function

A 4 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Cheonggukjang powder) on intestinal microflora and immunity function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011150

Enrollment

Registered

2025-11-12

Start date

2025-06-23

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

None listed

Interventions

Dietary Supplement : • Soybean Ferment TCC25-20 (Low-Content Functional Microorganism Cheonggukjang Powder) Group: Orally administered 1 sachet, once a day (after breakfast) (3.3 g/day, 2.97 g/day as

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged over 50 screening examination 2) Participants who had symptoms of upper respiratory infection (cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) at least twice within 12 months before screening examination 3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion criteria

Exclusion criteria: 1) Patients who have received influenza vaccination within 1 month before the screening test 2) Patients whose BMI is 18.5 kg/m^2 under or 35 kg/m^2 or over at the screening examination 3) Patients who have clinically significant acute or chronic cardio-cerebrovascular systems, endocrine systems, immune systems, respiratory systems, hepatic biliary systems, kidneys and urinary systems, neuropsychiatric systems, musculoskeletal systems, inflammatory and hematologic and tumorigenic, gastrointestinal diseases, etc. 4) Patients who have received anti-psychotic medication within three months before screening examinations 5) Patients with a history of significant hypersensitivity reaction to the ingredients of soybean, Fermented soybean(Cheonggukjang powder) 6) Patients who have or are suspected of alcoholism or substance abuse 7) Patients who have participated in other clinical trials within 3 months prior to the screening examination 8) Women who are pregnant or breastfeeding 9) Patients who have not accepted the implement of appropriate contraceptive method among women who are fertile 10) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
change of intestinal microbiome	—

Secondary

Measure	Time frame
Natural Killer cell activity;Cytokines;Patient global assessment;Inflammatory index;Short-chain fatty acids in feces;Wisconsin Upper Respiratory Symptom Survey-21	—

Countries

Korea, Republic of

Contacts

Public ContactSoo Wan Chae

Jeonbuk National University Hospital

swchae@jbctc.org+82-63-259-3040

Outcome results