The UK phytochemical rich food and probiotic, covid virus intervention study
The UK Phyto-v study

 

National ethics (IRAS): 282517
EudraCT: 2020-001532-1


This national randomised double blind placebo controlled trial established that boosting the diet with a specifically designed natural  phytochemical rich whole foods together with a specific  probiotic/prebiotic capsule reduced the severity of symptoms, improve gut health, speed up recovery and prevent late complications of a covid-19 infection.

The non-commercial and indenpendentally audited analysis, which recruited from May-Dec 2020, was designed and conducted  by a team of dedicated clinical and academic nutritionists, chest physicians, research pharmacist, consultants and scientists from Bedfordshire and Addenbrooke’s Cambridge University Hospitals. It was the World’s largest nutritional intervention study involving men and women with symptomatic covid-19 infection and attracted substantial academic and media attention (see below).

The first part of the analysis 

This involved 126 patients with symptomatic covid and looked at the impact of the probiotic now know as Yourgutplus+ 

The data was analysed as a whole and then subdivided into 40 (32%) in an early phase of infection (average symptoms 10 days before baseline) and the 86 (68%) in a chronic phase (average symptoms 120 days before trial baseline). Cough, fatigue and overall well-being scores all significantly improved  both the early and chronic phase cohorts. 

Participants who were more likely to have gut dysbiosis at trial entry, such as sedentary, hospitalised, older males with GI symptoms, had a statistically significantly better response to the probiotics. Gut symptoms improved in 25 of 31 (82%) who reported them at baseline. Two (1.5%) patients reported mild increased bloating and diarrhoea. 

The scientific committee of the journal concluded that although some participants with early disease would have improved spontaneously, such a rapid improvement in the majority who had been experiencing symptoms for over 6 months, was clinically relevant and welcomed, especially among those more likely to have pre-existing gut dysbiosis. 

 

Read a summary of the trail results and download full first paper)

 

 

 


The second part  

This involved 151 participants and analysed the impact of symptoms and outcomes after covid of the nutritional capsule now known as Phyto-V  

Participants were randomised to receive the ingredients of the phyto-V capsule in addition to the Yourgutplus+ capsule or a placebo (blinded so they did not know what they were taking). In addition to the benefit already received from the probiotic, there was a further 3 fold reduction in symptoms amoung participants who took phyto-v as opposed to placebo..

Read a summary of the trail results and download full second paper)

 


Future Research

A further study has now been ethically approved and will evaluate whether this probiotic/prebiotic blend with Vitamin D3 could enhance antibody titres post covid vaccine.

It will recruit 200 participants who a due for their covid booster vaccine. It will measure symptoms post vaccination, antibody titres (markers of success) and record post vaccine infection rates.


Background and rationale for the study

Treatments for covid-19 aim to support symptoms, secondary infection and thrombosis and ultimately to reduce the fatal cytokine storm. Although anyone can be affected by covid-19, data collected from hospitals across the world are showing that people with pre-existing health conditions or who are overweight are more vulnerable to the complications of infection and one possible explanation for this is a pre-existing poor gut health which could lead to a pro-inflammatory state.

Phytochemical rich concentrated foods are safe, can be developed rapidly and are ubiquitously available. Phytochemicals are naturally responsible for the colour, taste and aroma of foods. Their regular intake has been found to have multiple health benefits particularly reducing chronic degenerative disease and reducing excess chronic inflammation. Their biological mechanisms of action range from improving immune and oxidative capacity and efficiency to improving bacterial gut health. Laboratory studies investigating  of a wide range of herbs and plants have also reported potential direct anti-viral properties via 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.

Probiotic supplements have also been reported to  enhance gut flora, reducing chronic gut inflammation and improving gut wall integrity especially among individuals with preexisting health conditions or have diets high in sugar and meat and low in fruit and vegetables. A Cochrane review concluded probiotic capsules could reduce respiratory tract infections.It is important that probiotics are sources from GMP registered manufacturers and contain a wide spectrum of colony forming lactobacillus.

The phytochemicals particularly the polyphenol group, which show promise and are found in common foods include: The flavanone polyphenol hesperetin found in citrus fruits; Quertin, a flavonoid found in, onions, apple, pomegranate and citrus fruits; Apigenin a polyphenol found in parsley, chamomile, tea and fruit. Curcumin curcuminoids found in ellagic acid found in  pomegranate. Resveratrol found in grapes and polygonum cuspidatum root.

Certification, MHRA and legal considerations: This trial was sponsored by Bedfordshire NHS trust and designed by an international team of oncologist, intuitionalists and patients listed listed in the scientific committee. The national study was formally externally peer reviewed. It was registered and approved the National Ethics Committee, and registered by the National Institute of Health Research (NIHR). It was formally  notified as a non-drug intervention by the Medicines and Health Regulatory Agency (MHRA).


Chief investigator: 
Professor Robert Thomas
The Primrose Research Unit
Bedford and Cambridge University Hospitals
Professor of Exercise and Nutritional Science University of Bedfordshire


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