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

COVID-19 Clinical Trial

Official title:

A Randomised-controlled Trial of an Oral Microbiome Immunity Formula in Reducing Development of Long-term Co-morbidities in Recovered COVID-19 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04950803
• Other study ID #: RECOVERY
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of an oral microbiome immunity formula in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities in patients who have recovered from COVID-19.

Description:

SARS-CoV-2, the cause of COVID-19, emerged as a new zoonotic pathogen of humans at the end of 2019 and rapidly developed into a global pandemic. It may develop severe or critical disease with respiratory failure requiring oxygen support and intensive care.

Natural infection by virus triggers an effective system immunity so that the host can resist or highly reduce the chance of re-infection.

In many cases, this protection can maintain a long period of time. However, the long-term immunities (over a year) and complications from the patients are not yet very clear. We found that COVID-19 survivors who have cleared the virus continued to have persistent altered gut microbiota and up to 80 percent had residue COVID-19 related symptoms including fatigue, difficulty in breathing, impaired memory and hair loss up to 6 months after discharge (LONG COVID-19).

Earlier studies from our CU Medicine have shown a link between altered gut microbiome and COVID-19 severity, and more patients who received a novel microbiome immunity formula (SIM01) achieved complete symptom resolution and developed neutralising antibody than those who did not (unpublished data). Research from the Faculty also reported that almost 40% of people in Hong Kong had significant gut dysbiosis especially in elderly and patients with diabetes, obesity or chronic diseases.

This study is a single-centre, triple-blind, randomized, placebo-controlled clinical trial that aims to evaluate the effectiveness of an oral microbiome immunity formula (SIM01) invented by the Chinese University of Hong Kong (CUHK) in modulating gut microbiota, enhancing immunity and reducing long-term complications and co-morbidities (e.g. sepsis, cardiopulmonary complications, metabolic syndrome, neuropsychiatric disorders) in patients who have recovered from COVID-19.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 448
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Individuals aged 18 and above;

2. Subjects who are mentally capable to participate in the study and provide informed consent;

3. Subjects who can communicate in Chinese or English;

4. Subjects who are ambulatory and do not have difficulties travelling to the clinics for follow-up;

5. Subjects who do not have plans to leave Hong Kong in the subsequent two years after recruitment; and

6. Subjects who agree to give informed consent voluntarily.

Exclusion Criteria:

1. Subjects who are unable to receive oral fluids;

2. Subjects who have received surgery involving the intestine within past 30 days;

3. Subjects who are pregnant or breastfeeding; and

4. Subjects who are immunocompromised, e.g. on cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS.

Related Conditions & MeSH terms

• COVID-19
• Probiotic

Intervention

Dietary Supplement:
• Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3Bifidobacteria, 20 billion CFU daily)
• Active placebo
Active placebo contains active vitamin

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alleviation of symptoms or complications	Proportion of subjects with alleviation of symptoms or complication of post-COVID conditions within 6 months.	6 months
Secondary	Any comorbidities	A composite outcome of any comorbidities, including clinical manifestations of long-COVID, hospitalizations due to sepsis, cardiopulmonary complications, metabolic syndrome and neuropsychiatric disorders	24 months
Secondary	Increase in metabolic syndrome (MetS) score	a validated index computed from an analysis based on waist circumference, fasting triglycerides, fasting glucose, and systolic blood pressure, calculated in score (1-5), higher levels indicated higher probability of presence of metabolic syndrome	24 months
Secondary	Increase in other system-specific comorbidities	Increase in other system-specific comorbidities involving cardiovascular, gastrointestinal, liver, renal, genitourinary, haematological, and neurological systems	24 months
Secondary	Healthcare service utilization	The frequency of healthcare service (including clinics and Accident and Emergency) that the subject has attended	24 months
Secondary	Self-reported long-COVID-19 symptoms	Subjects will fill in a survey whether they have long-COVID-19 symptoms (e.g. cough, fatigue, etc) and grade the symptoms. The higher the score, the worse the outcome.	24 months
Secondary	Changes in Quality of life	Changes in Quality of life using visual analogue scale, score ranging 0-100. The higher the score, the better the outcome.	48 months
Secondary	Changes in faecal microbial and bacterial metabolites	Shotgun metagenomics and metabolomics sequencing of faecal samples at baseline and each visit will be used to generate serial gut microbial taxonomic and bacterial functional profiles.	48 months
Secondary	Blood immunity profiles	Inflammatory cytokines in plasma samples will be identified and quantified using human inflammation panel 1 (13-plex) of LEGENDplex	24 months

External Links

•   Hong Kong Government website
•   Quality of Life and Long-term Outcomes After Hospitalization for COVID-19.
•   WHO website