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Nutritional intervention for covid-19 patients - A RCT [COVID-19]

  • Research type

    Research Study

  • Full title

    A randomised double-blind, placebo-controlled trial evaluating the influence of a phytochemical-rich nutritional intervention and a lactobacillus (probiotic) supplement on clinical outcomes among individuals with covid-19 viral infection and their co-inhabitants.

  • IRAS ID

    282517

  • Contact name

    Robert Thomas

  • Contact email

    Robert.thomas@bedfordhospital.nhs.uk

  • Sponsor organisation

    Bedfordshire Hospitals NHS Foundation Trust

  • Eudract number

    2020-001532-10

  • Duration of Study in the UK

    0 years, 5 months, 0 days

  • Research summary

    The management for Covid-19 infection is supportive. Symptomatic patients are sent home, if not hypoxic, risking infecting their co-inhabitants. People with pre-existing health conditions or who are overweight have more complications and one possible explanation for this is a pre-existing poor gut health which could lead to a pro-inflammatory state. People living with chronic inflammation have reduced immunosurveillance (more likely to catch an infection) and inappropriate and yet often ineffectual excess inflammation against it. The main cause of death amongst patients with covid infection is the excessive cytokine (inflammatory) reaction. Phytochemical-rich concentrated foods are safe, can be developed rapidly and are ubiquitous. They have multiple health benefits in addition to their ability to improve gut health and reduce local and systemic inappropriate inflammation. They do not have direct anti-oxidant or anti-inflammatory effects, but improve oxidative and inflammatory capacity and efficiency. Laboratory studies have reported that some can reduce viral attachment, penetration, proliferation and shedding which, in theory, could help reduce the chance of catching the virus, suffering from it or spreading it to other people. The phytochemicals with the most promise include hesperetin and quertin found in citrus fruit, anthraquinone in Aloe Vera; apigenin in chamomile, and curcuminoids in turmeric; ellagic acid in pomegranate. Probiotic supplements can enhance gut health in unwell individuals and a Cochrane review concluded they could reduce respiratory tract infections. Laboratory study of a wide range of herbs and plants have also reported reduced viral attachment, penetration and absorption proliferation and shedding which in theory, if these benefits are extrapolated to humans to reduce the chase of catching the virus, suffering from it or spreading it to other people virus. We have a found a UK accredited manufacturer who is willing to stop all other production and make these whole food supplement containing these whole food extracts. They will perform all the appropriate quality assurance tests and make this legal and safe supplement within 2 weeks. In this study, instead of sending people home with advice only, they will be randomised to take a placebo or the whole food supplement together with their house mates. Via telephone the trials team will monitor their time to recovery (or not), symptoms as well as recording whether their house mates develop symptoms. [Study relying on COPI notice]

  • REC name

    Yorkshire & The Humber - Sheffield Research Ethics Committee

  • REC reference

    20/YH/0164

  • Date of REC Opinion

    22 May 2020

  • REC opinion

    Further Information Favourable Opinion