Post COVID-19 Syndrome and the Gut-lung Axis

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed
    • Enrollment target: estimated 20 to confirmed 21
    • Study completion date changed from estimate of Dec 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 6 words
  2. Minor Study completion date: Dec 2024 to Dec 2025v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Minor Study completion date: Dec 31, 2023 to Dec 2024v6
  5. Minor Study completion date: Dec 31, 2022 to Dec 31, 2023v5
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  1. Minor Primary completion date changed from estimate of Aug 31, 2022 to Jul 11, 2022v4
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: May 1, 2022 to Aug 31, 2022
    • Site details revised
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2021 to Jun 2, 2021
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04813718
Lead Sponsor Medical University of Graz
Collaborators: CBmed Ges.m.b.H.
Conditions
(from sponsor)
Covid19
Related terms COVID-19
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov