الفهرس 
IntroductionOnly 14 pages are availabe for public view
 |  | from | 172 |  |  |
| | | from | 172 | | |
Abstract
At the end of 2019, a novel coronavirus was identified as the causative of a cluster of pneumonia cases in Wuhan, China. resulting in an epidemic throughout China, followed by a global pandemic. In February 2020, the World Health Organization announced the disease COVID-19, which stands for coronavirus disease 2019.
Gut microbiota configuration was associated with COVID-19 disease severity, and altered gut microbiota persisted even after clearance of the virus, suggesting that the virus might inflict prolonged harm to human microbiome homoeostasis.
Probiotics as an intestinal microbe regulator, not only improve the ability of the GI microbiota to modulate immune activity, but also strengthen the body’s immune system, inhibit allergic reactions, and has a significant role especially in the anti-viral immunomodulation.
Colchicine is an anti-inflammatory medication commonly used for the treatment systemic auto inflammatory diseases such as familial Mediterranean fever and Behçet’s disease. Its mechanism of action is through inhibition of neutrophil chemotaxis and activity in response to vascular injury.
Therefore, in patients with COVID-19, probiotics and or Colchicine, may be a therapeutic choice. However, there is still a lack of evidence-based studies to support this, so it is necessary to conduct further studies and provide evidence to clinicians.
Objectives:
To assess effectiveness of probiotic supplement (Lactobacillus Acidophilus) and Colchicine on symptoms, duration, and progression of mild and moderate cases of COVID-19 infection.
Subjects and methods:
The study was a three-arm randomized controlled clinical trial conducted at Triage Clinic of Family Medicine Department at Ain Shams University Hospitals over a period of one year.
Inclusion Criteria: COVID-19 patients aged (18-64) with mild and moderate Severity.
Exclusion Criteria: COVID-19 patients aged below 18 years or above 65 years, with any co-morbidities, pregnant or lactating female and with severe COVID-19 confirmed cases
Sampling and study participants
The data was collected from 150 participants who met the inclusion criteria from the start of July 2021 till the end of August 2022.
Patients were selected from Triage/COVID-19 Outpatient Clinic and every patient subjected to the following: Clinical history were obtained about socio-demographic data such as age, gender, residence, marital status, smoking history...etc, medical history including (weight, current medication, symptoms (onset, course, duration) and presence of Co-morbidities. Full general examination including temperature, heart rate, blood pressure, respiratory rate and oxygen saturation.
Suspected patients according to CDC criteria were subjected to laboratory and radiological confirmation with (PCR-COVID-19, Complete Blood Count, CRP, Ferritin and D-Dimer) and High-resolution CT chest.
After confirmation of the diagnosis and patients were classified as mild and moderate with laboratory and radiological findings.
Grouping: All patients enrolled in the study according to the calculated sample size will be equally divided randomly into 3 groups using sealed envelope contain code for each group.
group A (Colchicine group): COVID-19 patients with mild and moderate severity who received the standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals plus Colchicine tablet (0.5 mg) 3 times/day for 3 days then twice daily for 4 days (13).
group B (Probiotic group): COVID-19 patients with moderate severity who received the standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals plus probiotics in the form of oral sachets once daily for two weeks.
group C (Control group): COVID-19 patients with mild and moderate severity who received the standard treatment according to the protocol of the Egyptian Supreme Council of University Hospitals (still not published) (Vitamin C 500mg tablet twice daily, Vitamin D3 2000–4000 IU/day, Zinc 75mg tablet once daily for two weeks and needed protocol of management according to case assessment and severity).
Randomization: The researcher used sealed envelopes containing code for intervention or control.
Follow up: Participants followed up twice weekly by telephone evaluating their symptoms (increase or decrease, duration of symptoms and development of new symptoms) compliance on treatment, daily measurement of temperature, oxygen saturation, need for oxygen inhalation, need for hospital admission, ICU admission, mechanical ventilation, mortality and improvement of inflammatory markers (CBC, CRP, Ferritin and D-dimer).
Final evaluation:
Discharge from isolation after 10 days after symptom onset or10 days after their first positive swab participants were asked about improvement of symptoms or residual symptoms and Complete Blood Count, CRP, Ferritin and D.Dimer were re-tested after 14 days of the start of treatment.
End point: The study continued up to complete the sample size, improvement of patient’s symptoms, no development of new symptoms, need for hospitalization or ICU admission and Occurrence of adverse events (AES) or serious adverse events (SAEs) throughout the study duration.
Ethical considerations
A required administrative and ethical committee board approval (Approval no MD 88/2020) to carry out the study at Ain Shams University hospitals have been obtained, data of approval 19/6/2021.
An informed consent was obtained from the patients which addresses all the steps of the study as well as their right to withdraw from the study at any time. Privacy and confidentiality of data will be also assured.
Results
A total of 150 patients with mild and moderate COVID-19severity were enrolled in the study, 50 patients in each arm, around one third (34.7%) the participants aged between 29 to 39 years, one-quarter of them (24.7%) aged between 18 to 28 years and (40.6 %) is aged 40 years and above. 68% reside in urbans, 57% in rural and 25% in urban slum areas, nearly one-quarter of them were smokers (23%),92% were married, 49% were university graduates 71% were housewives. there was no statistically significant difference between the three groups in terms of demographic data (Table 2).
Regarding the different clinical data of the participants: duration of symptoms, new symptoms, and residual symptoms after two weeks. Mean duration of symptoms was (12, 11, 12) in the colchicine, probiotic, and control group respectively. and it wasn’t also statistically significant (p value >0.05). Most patients (54%, 46%, 56%) cured with residual symptoms after 2 weeks with no difference in between the three groups. Severity of symptoms increased over one week then decreased in most of patients (56.7%, 60%, 60%) in the three groups respectively. In general, the mean difference regarding clinical data wasn’t statistically significant in between the three groups expect for the development of new symptoms (mostly myalgia) (16%, 56%, 4%) in the three groups respectively.
The percentage of side effects in the Colchicine group, the current study 44% of the colchicine group participants have experienced gastrointestinal adverse events.
Regarding laboratory data, a statistically significant difference in all the parameters before and after intervention
Improvement of inflammatory markers over time occurred in each of the three groups with no statistically significant difference in between them.
Conclusion
• Neither probiotic Lactobacillus acidophilus nor Colchicine have a significant effect on symptoms, duration, and progression of mild and moderate cases of COVID-19. Colchicine adds more gastrointestinal adverse events in the form of diarrhea to the participants.
• Recommendation
• There is no role for probiotic supplementation or colchicine in mild and moderate cases of COVID-19.
• CBC, CRP, ferritin, and D-dimer may be employed as prognostic and follow-up tools for both disease severity and outcomes.
• Further randomized controlled trials with a larger sample size could be conducted to confirm these results.