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A human trial of Fermented hot pepper(Gochujang powder) on intestinal microflora and immunity function

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010080
Enrollment
45
Registered
2024-12-26
Start date
2024-07-19
Completion date
Unknown
Last updated
2025-01-06

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 : • TCG24-12(high content of Effective Microorganisms, gochujang powder): 2 times a day, 3 packs once, after breakfast/dinner, a duration of 4 weeks(25.3 g/day, 19 g/day for gochuja

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

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 red pepper and red pepper paste ingredients 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

MeasureTime frame
change of intestinal microbiome

Secondary

MeasureTime frame
Natural Killer cell activity;Cytokines;Fatigue Severity Scale;Patient global assessment;Inflammatory index;Short-chain fatty acids in feces

Countries

Korea, Republic of

Contacts

Public ContactSoo Wan Chae

Jeonbuk National University Hospital

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

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026