A Randomised-controlled Trial of an Oral Microbiome Immunity Formula in Recovered COVID-19 Patients

Not Applicable

Active, not recruiting

• Conditions: COVID-19; Probiotic

• Registration Number: NCT04950803
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-6-21
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Individuals aged 18 and above;<br><br> 2. Subjects who are mentally capable to participate in the study and provide informed<br> consent;<br><br> 3. Subjects who can communicate in Chinese or English;<br><br> 4. Subjects who are ambulatory and do not have difficulties travelling to the clinics<br> for follow-up;<br><br> 5. Subjects who do not have plans to leave Hong Kong in the subsequent two years after<br> recruitment; and<br><br> 6. Subjects who agree to give informed consent voluntarily.<br><br>Exclusion Criteria:<br><br> 1. Subjects who are unable to receive oral fluids;<br><br> 2. Subjects who have received surgery involving the intestine within past 30 days;<br><br> 3. Subjects who are pregnant or breastfeeding; and<br><br> 4. Subjects who are immunocompromised, e.g. on cancer treatment, bone marrow/organ<br> transplant, immune deficiency, poorly controlled HIV/AIDS.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alleviation of symptoms or complications

Secondary Outcome Measures

Name	Time	Method
Any comorbidities;Increase in metabolic syndrome (MetS) score;Increase in other system-specific comorbidities;Healthcare service utilization;Self-reported long-COVID-19 symptoms;Changes in Quality of life;Changes in faecal microbial and bacterial metabolites;Blood immunity profiles