ABSTRACT
Aim. To determine the clinical efficacy and safety of the immobilized (sorbed) probiotics Bifidobacterium bifidum 1 (5x108 CFU) and B. bifidum 1 (5x107 CFU) in combination with Lactobacillus plantarum 8P-A3 (5x107 CFU) in the complex therapy of pneumonia caused by SARS-CoV-2 in adult patients without severe risk factors and their impact on health-related quality of life (QoL). Material and methods. An open, randomized prospective study included 100 patients (45 males, 55 females), aged from18 to 60 years without risk factors for severe COVID-19, with pneumonia confirmed by computed tomography and an area of lung lesion no more than 75% (moderate forms). SARS-CoV-2 RNA in nasal and oropharyngeal swabs (RT-PCR) was detected in 72% of the participants, in the rest it was highiy probable in terms of the aggregate parameters. The publication presents the results of self-assessment (94 respondents) of working capacity limitations, shortness of breath, intestinal disorders since the end of the probiotic regimen (PR: hospitalization period - B. bifidum 1, 3 capsules 2 times a day for 10 days, then after hospitalization - B. bifidum 1 in combination with L. plantarum 8P-A3 2 powders 3 times a day for 14 days) and QoL (Short Form Medical Outcomes Study: SF-36) 1 month after hospitalization. Results. At the end of PR, the ability to engage in daily activities was higher by 23.1% [95% confidence interval 5.3-37.3, OR 0.08 (0.08-0.77)]. Difficulty of breathing during exercise was less common by 29.7% [15.1-44.5%], OR 0.09 [0.02-0.40], hard stools and no bowel movements were recorded less often by 21.3% [8.5-34, 1] for 1-3 days. One month after hospitalization, the QoL of the patients receiving standard treatment was significantly reduced relative to population indicators in Russia. It was more significantly due to the psychological component of health [total measurement 38.1 (36.2-40.0)] and less significantly due to the physical component [49.5 (48.3-50.8)]. The main reasons limiting daily activities [Role Emotional (RE): 39.4 (37.4-41.4)] were decreased vitality [VT: 40.2 (38.9-041.5)], emotional depression [Mental Health (MH): 41.2 (39.4-43.0)], deficit of social contacts [Social Functioning (SF): 45.1 (43.7-46.6)]. The patients who received PR had a higher ability to carry out daily activities [RE: 57.7 (55.6-59.7)], the severity of psychological problems associated with fatigue, anxiety and depression was lower [MH: 59.8 (58.7-60.9), p<0,001]. The effect of the PR on negative perceptions of social isolation was comparatively less [SF: 53.9 (52.2-55.4)]. The QoL of the patients who additionally suffered from diarrhea in the acute period of SARS-CoV-2 pneumonia was worse in comparison with the patients without diarrhea (due to pain and inability to endure physical activity). The effects of immobilized (sorbed) probiotics to the QoL of the patients with diarrhea during the acute period of COVID-19 were most significant. Conclusion. PR had a significant positive effect on the QoL within a month after hospitalization, increasing working capacity and improving mental health, reducing the severity of psychological problems and fatigue. Additional researches are needed on the possible relationship of organic and functional gastrointestinal diseases with the progression of diarrhea in patients infected with SARS-CoV-2. No side effects of the sorbed probiotics regimen have been identified.Copyright © Eco-Vector, 2022.
ABSTRACT
Aim. To determine the clinical efficacy and safety of the immobilized (sorbed) probiotics Bifidobacterium bifidum 1 (5×108 CFU) and B. bifidum 1 (5×107 CFU) in combination with Lactobacillus plantarum 8P-А3 (5×107 CFU) in the complex therapy of pneumonia caused by SARS-CoV-2 in adult patients without severe risk factors and their impact on health-related quality of life (QoL). Material and methods. An open, randomized prospective study included 100 patients (45 males, 55 females), aged from18 to 60 years without risk factors for severe COVID-19, with pneumonia confirmed by computed tomography and an area of lung lesion no more than 75% (moderate forms). SARS-CoV-2 RNA in nasal and oropharyngeal swabs (RT-PCR) was detected in 72% of the participants, in the rest it was highiy probable in terms of the aggregate parameters. The publication presents the results of self-assessment (94 respondents) of working capacity limitations, shortness of breath, intestinal disorders since the end of the probiotic regimen (PR: hospitalization period – B. bifidum 1, 3 capsules 2 times a day for 10 days, then after hospitalization – B. bifidum 1 in combination with L. plantarum 8P-А3 2 powders 3 times a day for 14 days) and QoL (Short Form Medical Outcomes Study: SF-36) 1 month after hospitalization. Results. At the end of PR, the ability to engage in daily activities was higher by 23.1% [95% confidence interval 5.3–37.3, OR 0.08 (0.08–0.77)]. Difficulty of breathing during exercise was less common by 29.7% [15.1–44.5%], OR 0.09 [0.02–0.40], hard stools and no bowel movements were recorded less often by 21.3% [8.5–34, 1] for 1–3 days. One month after hospitalization, the QoL of the patients receiving standard treatment was significantly reduced relative to population indicators in Russia. It was more significantly due to the psychological component of health [total measurement 38.1 (36.2–40.0)] and less significantly due to the physical component [49.5 (48.3–50.8)]. The main reasons limiting daily activities [Role Emotional (RE): 39.4 (37.4–41.4)] were decreased vitality [VT: 40.2 (38.9–041.5)], emotional depression [Mental Health (MH): 41.2 (39.4–43.0)], deficit of social contacts [Social Functioning (SF): 45.1 (43.7–46.6)]. The patients who received PR had a higher ability to carry out daily activities [RE: 57.7 (55.6–59.7)], the severity of psychological problems associated with fatigue, anxiety and depression was lower [MH: 59.8 (58.7–60.9), р<0,001]. The effect of the PR on negative perceptions of social isolation was comparatively less [SF: 53.9 (52.2–55.4)]. The QoL of the patients who additionally suffered from diarrhea in the acute period of SARS-CoV-2 pneumonia was worse in comparison with the patients without diarrhea (due to pain and inability to endure physical activity). The effects of immobilized (sorbed) probiotics to the QoL of the patients with diarrhea during the acute period of COVID-19 were most significant. Conclusion. PR had a significant positive effect on the QoL within a month after hospitalization, increasing working capacity and improving mental health, reducing the severity of psychological problems and fatigue. Additional researches are needed on the possible relationship of organic and functional gastrointestinal diseases with the progression of diarrhea in patients infected with SARS-CoV-2. No side effects of the sorbed probiotics regimen have been identified. © Eco-Vector, 2022.
ABSTRACT
AIM: To determine the clinical efficacy and safety of the sorbed probiotics Bifidobacterium bifidum 1 (5108 KÐÐ) and B. bifidum 1 (5107 KÐÐ) in combination with Lactobacillus plantarum 8P-Ð3 in the complex therapy of pneumonia caused by SARS-CoV-2 in adult patients without severe risk factors. MATERIALS AND METHODS: An open, randomized prospective study included 100 patients (45 men, 55 women), aged 18 to 60 years without risk factors for severe COVID-19 with pneumonia confirmed by computed tomography, and an area of lung lesion no more than 75% (moderate forms). SARS-CoV-2 RNA in nasal and oropharyngeal swabs (RT-PCR) was detected in 72% of the participants, in the rest it was highly probable in terms of the aggregate parameters. Diagnostics of COVID-19 and its severity, the appointment of a standard examination and treatment were carried out in accordance with the Temporary Methodological Recommendations of the Ministry of Health of Russia, version 8 of 09.03.2020. This publication presents the results of using B. bifidum 1 (3 capsules twice a day for 10 days) during the peak of clinical manifestations (in a hospital). RESULTS: In those who received sorbed B. bifidum 1, by the 10th day of treatment, the frequency of weakness was 32% lower (RR 0.55 [95% CI 0.240.73], OR 0.25 [0.110.59]); hypoosmia/dysgeusia by 22% (RR 0.42 [0.050.65], OR 0.40 [0.170.90]) and cough by 24% (RR 0.39 [0.070.60], OR 0.38 [0.170.84]). B. bifidum 1 reduced the average duration of weakness by 3 days [1.14.9], hypoosmia/dysgeusia by 3.2 days [1.35.1], cough by 1.9 days [0.43,4], dyspnea by 1.8 days [0.72.7], diarrhea by 1.7 days [0.13.5]; reduced the risk of antibiotic-associated diarrhea by 20% (RR 0.77 [0.240.93], OR 0.18 [0.050.68]). Due to the deterioration of the condition and the increase in the symptoms of respiratory failure, additional treatment was required less often by 24% (p=0.005). After the end of the intervention, the frequency of virologic debridement, levels of CRP, leukocytes, lymphocytes, platelets and the degree of lung damage on computed tomography did not statistically differ in the compared groups. No side effects of B. bifidum 1 (5108 KÐÐ) have been identified. CONCLUSION: The use of sorbed B. bifidum 1 (5108 KÐÐ) improved the well-being of patients without risk factors with moderate viral (SARS-CoV-2) pneumonia and reduced the duration of diarrheal syndrome in a short time. The safety profile of their use was high. More research is needed to clarify the anti-inflammatory effects of the sorbed probiotic.