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Virus Therapy
Beta-glucan for Flu Vaccine Response (M-Unity Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have been immunized for COVID-19
Adult volunteers ≥ 50 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days (day 1, day 14, day 15, and day 42)
Summary
This trial will test if a supplement can help the flu vaccine work better.
Who is the study for?
This trial is for healthy adults over 50 who plan to get the flu shot, can follow study procedures like blood draws and questionnaires, have had their COVID-19 shots, and can consent in English. It's not for those in other trials that might affect results, with severe vaccine reactions or immune system issues due to illness or treatments.
What is being tested?
The trial tests if beta-glucan (a fiber from baker's yeast) affects the body's response to the flu vaccine compared to a placebo. Participants will receive either beta-glucan or a dummy pill alongside their regular influenza vaccination.
What are the potential side effects?
Possible side effects may include typical responses to dietary supplements such as digestive discomfort. The flu vaccine itself may cause soreness at injection site, mild fever, or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received the COVID-19 vaccine.
Select...
I am 50 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days (day 1, day 14, day 15, and day 42)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days (day 1, day 14, day 15, and day 42)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Antibody Titer
Secondary study objectives
Cold and flu symptoms
Fever
Incidence of influenza and Covid-19
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Beta-glucanExperimental Treatment2 Interventions
500 mg/day beta-glucan
Group II: PlaceboPlacebo Group2 Interventions
500 mg/day cellulose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza Vaccine
2022
Completed Phase 4
~16570
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,395 Previous Clinical Trials
767,202 Total Patients Enrolled
Danstar Ferment AGUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received the COVID-19 vaccine.I am willing and able to follow all study requirements, including visits, vaccines, supplements, and questionnaires.I am 50 years old or older.My immune system is weakened due to an illness or treatment I've received.You had a bad reaction to a flu shot, another vaccine with the same ingredients, or the study drug before.You are planning to get the flu vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Beta-glucan
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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