NCT06724185

Brief Summary

Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

12 months

First QC Date

December 4, 2024

Last Update Submit

December 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • WURSS-24

    The WURSS-24 (Wisconsin Upper Respiratory Symptom Survey-24) is a questionnaire designed to assess the impact of upper respiratory tract infections, such as the common cold, on daily life and health. It includes 24 questions covering symptoms (e.g., cough, runny nose, fatigue) and how they affect daily activities, work, and social interactions. Patients rate each item on a scale from 0 (no problem) to 7 (severe problem).

    From enrollment to the end of treatment at 12 weeks (measure daily)

Secondary Outcomes (7)

  • Immune cell ratio

    From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

  • NK cell activity

    From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

  • Cytokines measurement

    From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

  • sIgA

    From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

  • α-amylase

    From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)

  • +2 more secondary outcomes

Study Arms (2)

LP28 capsule

EXPERIMENTAL

Subjects will take two capsule of the experimental group(LP28 capsule) within 30 minutes before breakfast and dinner each day.

Dietary Supplement: LP28 capsule

Placebo capsule

PLACEBO COMPARATOR

Subjects will take two placebo capsule within 30 minutes before breakfast and dinner each day.

Dietary Supplement: Placebo Capsule

Interventions

LP28 capsuleDIETARY_SUPPLEMENT

LP28 capsule : 5.0×10\^9 CFU/capsule

LP28 capsule
Placebo CapsuleDIETARY_SUPPLEMENT

Maltodextrin

Placebo capsule

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who had symptoms of common cold or tonsillitis at least twice in the past year.

You may not qualify if:

  • People who have liver, kidney, immune, or neoplastic diseases diagnosed by doctor.
  • People with mental illnesses such as schizophrenia or depression.
  • People who have allergic rhinitis.
  • People who have a current condition of drug or alcohol dependence.
  • Any person is deemed inappropriate by the researcher for the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Chung Hsing University

Taichung, 402202, Taiwan

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 9, 2024

Study Start

July 9, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations