Table 1.
Summary of registered intervention clinical trials of dietary supplementation with probiotics in the prevention or treatment of symptoms or side effects of COVID-19 including mental health issues outcome measures (via https://www.clinicaltrials.gov/, accessed on 25 July 2022).
| Clinical Trials Identifier and Status |
Location | Official Title | Evaluation | Hypothesis | Intervention | Mental Health Outcomes Measures | Participants | Reference |
|---|---|---|---|---|---|---|---|---|
| NCT04507867, Completed | Toluca de Lerdo, Mexico | Effect of an NSS to reduce complications in patients with COVID-19 and comorbidities in stage III | Randomized clinical trial | The nutritional support system will reduce the complications of patients with COVID-19 in stage III with comorbidities | Nutritional support system (NSS), which consists of probiotics Saccharomyces boulardii 50 million CFU daily for 6 days orally and placebo | PHQ-9 test * | 80 | https://clinicaltrials.gov/ct2/show/NCT04507867 (accessed on 25 July 2022) |
| NCT03851120, Active, not recruiting | Jakarta, Indonesia | Promotion of maternal gut microbiota and psychological stimulation on child cognitive development at 6 months of age | Randomized clinical trial and placebo parallel controlled study, followed by a follow-up study at 2 years old | Maternal probiotic + LC-PUFA supported with government program supplements, healthy eating, and psychosocial stimulation affect fetal brain development and later child brain functions and cognitive development in light of the COVID-19 outbreak | Probiotics and 480 mg DHA, psychosocial stimulation, healthy eating education, and placebo | Mother’s depression test, mother quality of life, child cognitive at 4, 6, 25–28 months of age, child brain function at 4 months of age | 314 | https://www.clinicaltrials.gov/ct2/show/NCT03851120 (accessed on 25 July 2022) |
| NCT04884776, Recruiting | Hong Kong, Hong Kong | Modulation of gut microbiota to enhance health and immunity of vulnerable individuals during COVID-19 pandemic | A double-blinded, randomized, active-placebo controlled study | Modulating the gut microbiota with a microbiome immunity formula can rebalance the gut microbiota in populations at risk of infection, like, patients with type 2 DM and elderlies and can lower the number of hospitalization and reduce side effects associated with COVID-19 vaccination | Microbiome immunity formula 2 sachets daily for a total of 12 weeks (3 Bifidobacteria, 10 billion CFU per sachet) and placebo contains active vitamin | EQ-5D-5L questionnaire ** | 484 | https://clinicaltrials.gov/ct2/show/NCT04884776 (accessed on 25 July 2022) |
| NCT04950803, Recruiting | Hong Kong, Hong Kong | A randomized controlled trial of an oral microbiome immunity formula in reducing the development of long-term co-morbidities in recovered COVID-19 patients | Multi-center, triple-blind, randomized, placebo-controlled clinical trial | The oral microbiome immunity formula (SIM01) modulates gut microbiota, enhancing immunity and reducing long-term complications and comorbidities in patients who have recovered from COVID-19 | Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet) daily for 3 months and a placebo | Neurological system issues | 280 | https://clinicaltrials.gov/ct2/show/NCT04950803 (accessed on 25 July 2022) |
| NCT04922918, Recruiting | Moralzarzal, Spain | Administration of Ligilactobacillus salivarius MP101 in an elderly nursing home during the COVID pandemics | Open-label study | Ligilactobacillus salivarius MP101 influences the functional, cognitive, and nutritional status, and the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by COVID-19 | Administration of Ligilactobacillus salivarius MP101 (>9 log10 CFU, daily) for 4 months | GDS/FAST system (cognitive status) *** | 25 | https://clinicaltrials.gov/ct2/show/NCT04922918 (accessed on 25 July 2022) |
* PHQ-9 test evaluates the presence of depressive symptoms based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders version 4; ** EQ-5D-5L questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; *** GDS/FAST which is the Global Deterioration Scale/Functional Assessment Staging system, assesses of disease severity in progressive dementing illness.