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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04950803
Recruitment Status : Active, not recruiting
First Posted : July 6, 2021
Last Update Posted : July 21, 2023
Sponsor:
Information provided by (Responsible Party):
Siew Chien NG, Chinese University of Hong Kong

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Probiotic Dietary Supplement: Microbiome immunity formula Dietary Supplement: Active placebo Not Applicable

Detailed 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formula (SIM01) achieved complete symptom resolution and developed neutralising antibody than those who did not (unpublished data).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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : June 25, 2021
Estimated Primary Completion Date : May 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active arm
Subjects will take microbiome immunity formula (SIM01) daily for 6 months
 Dietary Supplement: Microbiome immunity formula
Microbiome immunity formula contains probiotics blend (3Bifidobacteria, 20 billion CFU daily)
Placebo Comparator: Placebo arm
Subjects will take active vitamin daily for 6 months
 Dietary Supplement: Active placebo
Active placebo contains active vitamin


Outcome Measures
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Primary Outcome Measures :
  1. Alleviation of symptoms or complications [ Time Frame: 6 months ]
    Proportion of subjects with alleviation of symptoms or complication of post-COVID conditions within 6 months.


Secondary Outcome Measures :
  1. Any comorbidities [ Time Frame: 24 months ]
    A composite outcome of any comorbidities, including clinical manifestations of long-COVID, hospitalizations due to sepsis, cardiopulmonary complications, metabolic syndrome and neuropsychiatric disorders

  2. Increase in metabolic syndrome (MetS) score [ Time Frame: 24 months ]
    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

  3. Increase in other system-specific comorbidities [ Time Frame: 24 months ]
    Increase in other system-specific comorbidities involving cardiovascular, gastrointestinal, liver, renal, genitourinary, haematological, and neurological systems

  4. Healthcare service utilization [ Time Frame: 24 months ]
    The frequency of healthcare service (including clinics and Accident and Emergency) that the subject has attended

  5. Self-reported long-COVID-19 symptoms [ Time Frame: 24 months ]
    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.

  6. Changes in Quality of life [ Time Frame: 48 months ]
    Changes in Quality of life using visual analogue scale, score ranging 0-100. The higher the score, the better the outcome.

  7. Changes in faecal microbial and bacterial metabolites [ Time Frame: 48 months ]
    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.

  8. Blood immunity profiles [ Time Frame: 24 months ]
    Inflammatory cytokines in plasma samples will be identified and quantified using human inflammation panel 1 (13-plex) of LEGENDplex


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950803


Locations
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Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Siew Ng CUHK-M&T
More Information
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Additional Information:

Publications:

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Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04950803    
Other Study ID Numbers: RECOVERY
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases