LC-Plasma for Preventing URTIs and Reducing Symptoms

RDC Clinical

Status and phase: Active, not recruiting; Phase 3

Conditions: Healthy Volunteer; URTI

Treatments: Other: Placebo; Dietary Supplement: LC-Plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT06827327

KURTIS

Details and patient eligibility

About

The goal of this study is to evaluate the efficacy of the LC-Plasma in preventing upper respiratory tract infections (URTIs) in healthy volunteers. Researchers will compare LC-Plasma to placebo to see if LC-Plasma prevents URTIs. Participants will take a tablet containing LC-Plasma or placebo daily for 24 weeks.

Enrollment: 650 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18-60 years living in Australia
• Individuals with a history of recurrent upper respiratory tract infections
• Able to provide informed consent
• Generally healthy
• Agree to not participate in another clinical trial while enrolled in this trial
• Agree to maintain their usual daily activities without significant changes. This includes not changing their current diet or stopping/starting a new exercise regimen during entire study period
• Agree not to travel internationally for over 1 month in a single trip during the intervention period (baseline to study completion).
• Females of childbearing potential must a prescribed form of birth control

Exclusion criteria

• Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
• Unstable illness e.g., changing medication/treatment.
• BMI <18.5, >30
• Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
• Individuals with chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
• Has current symptoms of an acute sickness.
• Active smokers, nicotine use or drug (prescription or illegal substances) abuse
• Current alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in the active or placebo formula
• Pregnant or lactating woman
• People medically prescribed medications within the last month that would affect the immune and/or the inflammatory response excluding topical steroid use.
• Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
• Participants with cognitive damage
• Participants with seasonal allergic rhinitis
• Regular use of antihistamines
• Individuals deemed unsuitable for participation by the Principal Investigator (PI) of this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

650 participants in 2 patient groups, including a placebo group

LC-Plasma

Experimental group

Description:

1 tablet containing 50mg LC-Plasma is taken daily for 24 weeks.

Treatment:

Dietary Supplement: LC-Plasma

Placebo

Placebo Comparator group

Description:

1 tablet containing 50mg microcrystalline cellulose is taken daily for 24 weeks

Treatment:

Other: Placebo