Post COVID-19 Syndrome and the Gut-lung Axis

Covid19 Clinical Trial

Official title:

Post COVID-19 Syndrome: A Pilot Study to Explore the Gut-lung Axis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04813718
• Other study ID #: PostCov
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The outbreak of the novel coronavirus (SARS-CoV-2)-infected disease (COVID-19) began in December 2019, spread throughout China in early 2020 and developed as a pandemic thereafter. Based on current knowledge, Covid-19 infection causes mild to moderate respiratory and gastrointestinal symptoms in the majority of patients. In a smaller percentage severe disease courses are observed, often with the need of hospitalization and intensive care treatment. Apparently, symptoms can persist for relatively long time after viral clearance, suggesting the existence of a "Post-Covid" syndrome. A study from the UK identified fatigue, breathlessness and psychosocial stress as common symptoms after discharge from the hospital. Covid-19 infection is frequently characterized by a hyperinflammatory phenotype and a cytokine storm. The Covid-19 cytokine storm is characterised by rapid proliferation and hyperactivation of T cells, macrophages, mast cells, neutrophil granulocytes and natural killer cells, and the overproduction of inflammatory cytokines and chemical mediators released by immune or nonimmune cells. Early data also suggest that even if symptoms are just 'mild to moderate' during the acute infection, fibrotic lung damage develops in some patients. This may lead to long-term pulmonary complications for a subset of patients. The mechanisms for post-Covid pulmonary fibrosis are still unclear: inflammation triggering fibrosis, epithelial and endothelial injury with inadequate fibroproliferation and vascular damage are considered to be possible mechanisms. A potential therapeutic target in ameliorating post-Covid symptoms could be the gut microbiome. Gut microbiome alterations have been described in Covid-19. The gut-lung axis as a link between dysbiosis, barrier dysfunction, translocation of bacterial products and hyperinflammation has been proposed as a potential therapeutic target. Probiotics have been proposed to be a possible modulator of the deranged gut-lung axis in Covid-disease and post-Covid syndrome. Currently 11 studies are registered in clinicaltrials.gov for treatment of acute Covid disease and prevention of the disease (including one study from Graz), but no study related to post-Covid syndrome could be found. Therefore, it is currently unclear, which clinical, immune system or microbiome related biomarker would be the best to study the effect of a microbiome-based intervention in post-Covid syndrome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Covid-19 infection with severe disease defined within the last 12 months (defined as one or more of the following: hospitalization, need for oxygen supply, need for intensive care treatment, need for specific treatment of Covid disease, antibiotic treatment)
• Subjective presence of residual symptoms of Covid disease OR no residual symptoms of Covid disease (Controls)
• Informed consent

Exclusion Criteria:

• Continuous probiotic treatment in the last 4 weeks before inclusion
• Pre-existing lung diseases

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Dietary Supplement:
• Omni-Biotic Pro Vi 5
Pre- and probiotic
• Placebo
Placebo

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	CBmed Ges.m.b.H.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiome composition	16 sRNA sequencing	6 months
Primary	Intestinal barrier	Change in zonulin levels over time and with/without the intervention	6 months
Primary	sCD14	Change in sCD14 levels over time and with/without the intervention	6 months
Primary	endotoxin	Change in endotoxin levels serum over time and with/without the intervention	6 months
Primary	TNFalpha	Change in TNFalpha levels serum over time and with/without the intervention	6 months
Primary	Interleukin 1b	Change in Interleukin 1b serum levels over time and with/without the intervention	6 months
Primary	Interleukin 6	Change in interleukin 6 serum levels over time and with/without the intervention	6 months
Primary	Interleukin 6 receptor	Change in Interleukin 6 receptor serum levels over time and with/without the intervention	6 months
Primary	interleukin 8	Change in interleukin 8 serum levels over time and with/without the intervention	6 months
Primary	interleukin 10	Change in interleukin 10 serum levels over time and with/without the intervention	6 months
Primary	interleukin 17	Change in interleukin 17 serum levels over time and with/without the intervention	6 months
Primary	interleukin 23	Change in interleukin 23 serum levels over time and with/without the intervention	6 months
Primary	neutrophil function burst function	Change in neutrophil burst function over time and with/without the intervention	6 months
Primary	neutrophil function phagocytosis	Change in neutrophil phagocytosis function over time and with/without the intervention	6 months
Primary	neutrophil NET formation	Change in neutrophil NET formation over time and with/without the intervention	6 months
Primary	neutrophil surface receptor expression	Change in neutrophil surface receptor expression over time and with/without the intervention	6 months
Primary	monocyte burst	Change in monocyte burst over time and with/without the intervention	6 months
Primary	monocyte phagocytosis	Change in monocyte phagocytosis over time and with/without the intervention	6 months
Primary	monocyte function surface receptor expression	Change in monocyte surface receptor expression over time and with/without the intervention	6 months
Primary	T cell immunophenotyping	Change in T cell subtypes over time and with/without the intervention	6 months
Primary	B cells immunophenotyping	Change in B cell subtypes over time and with/without the intervention	6 months
Primary	Spirometry	Change in spirometry measurements over time and with/without the intervention	6 months
Primary	Lung volume	Change in lung volume over time and with/without the intervention	6 months
Primary	Gas diffusion	Change in pulmonary gas diffusion over time and with/without the intervention	6 months