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Full eligibility criteria for NCT02909842
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
18 45 years old
healthy and having normal vital signs
no history of uncontrolled systemic or autoimmune diseases
no signs or symptoms of respiratory infection
normal blood chemistry including complete blood count (CBC), liver and kidney function, lipid profile and fasting blood sugar
no history of influenza vaccine during the past 6 months
able to continuously take the intervention daily for 6 weeks
able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection
accepted to receive influenza vaccine shot
able to refrain from receiving other vaccine during the trial
able to refrain from traveling to endemic area of influenza
able to communicate in Thai and sign their written inform consent
under pregnancy or expected to be pregnant
lactose or milk protein intolerances
daily intake of probiotic product for one month prior to recruitment
GI disturbance e.g. stomachache, frequent diarrhea or constipation
history of GI surgery
ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids
All locations for NCT02909842
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Tris trial is registered with FDA with number: NCT02909842. The sponsor of the trial is Mahidol University and it is looking for 60 volunteers for the current phase.
Official trial title: Immunomodulating Effects of Drinking Fermented Milk Containing Lactobacillus Paracasei (IMULUSTM): a Randomized Controlled Trial Using an Influenza Vaccination Model
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