Probiotic
Dietary SupplementProbiotic will be taken 1 time a day before breakfast for 28 days.
NCT Number: NCT04907877
There is evidence that some types of probiotics play a role in alleviation of symptoms of acute respiratory tract infections and bursting immune response to respiratory and enteric viruses. Available data serves a rationale for the study exploring a role of nutritional support with probiotics in adult outpatients with COVID-19. Hypothesis of the study is that a proposed mixture of lactobacilli and bifidobacteria facilitate faster recovery from COVID-19 and enhance specific immune response to SARS-CoV-2 antigens.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Hemo Medica Ukraine Ltd, Uzhhorod, Zakarpatska, Ukraine
One hundred adults with confirmed (PCR or antigen test) symptomatic COVID-19 lasting upto 5 days will be screened for the study. When the subject meets enrollment criteria, he/she will be randomized to take an investigational product (probiotic, test dietary supplement, TDS), a mixture of lactobacilli and bifidobacteria or placebo 1 time a day before breakfast for 28 days after enrollment. During observation, the patient will keep Respiratory Illness Diary. Blood serum will be collected at baseline, day 0-5 (Nurse Visit 1), after 28-35 days (Nurse visit 2), and 6 months (Nurse visit 3) for evaluation of anti-SARS-CoV-2 antibodies to nucleocapsid and spike antigents. In 3 months, investigator/family physician will collect Post-COVID-19 Questionnaire
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.1. Hypertension; 1.2. Diabetes mellitus; 1.3. Immunosuppressive conditions; 1.4. Chronic pathology of the respiratory system ; 1.5. Chronic pathology of the cardiovascular system ; 1.6. Malignant tumor ; 1.7. Systemic inflammatory connective tissue disease ; 1.8. Cerebrovascular disease ; 1.9. Chronic hepatitis. Hepatic cirrhosis; 1.10. Inflammatory bowel diseases ; 1.11. Chronic kidney disease ;
Probiotic will be taken 1 time a day before breakfast for 28 days.
Placebo will be taken 1 time a day before breakfast for 28 days.
Time frame: 10 days
Clinical score of Coronavirus disease-19; minimal score 0 (healthy), maximal score 36 (worst disease)
Time frame: 28 days
World Health Organization scale; score 0 - healthy, score 8 - death
Time frame: 28 days
Day when patient symptom score is 0
Time frame: 28 days
Patients with symptom score is 0
Time frame: 28 days
Percent hospitalized due to COVID-19
Time frame: Days 0-5, day 28-35, month 6th
Antibody titer to NCP and spike antigen
Nordic Biotic Sp. z o.o.
Industry
Role of Nutritional Support With Probiotics in Adult Outpatients With Symptomatic COVID-19: a Randomized Dietary Study
Acronym: ProCOVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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