A Randomised, Double-Blind, Placebo-Controlled Trial Evaluating Concentrated Phytochemical-Rich Nutritional Capsule in Addition to a Probiotic Capsule on Clinical Outcomes among Individuals with COVID-19—The UK Phyto-V Study
Thomas et al.,
A Randomised, Double-Blind, Placebo-Controlled Trial Evaluating Concentrated Phytochemical-Rich Nutritional..,
COVID, doi:10.3390/covid2040031, Phyto-V
RCT 147 long COVID patients in the UK, 56 treated with a phytochemical-rich concentrated food capsule, showing improved recovery with treatment. Treatment included curcumin, bioflavonoids, chamomile, ellagic acid, and resveratrol.
relative improvement, 44.3% better, RR 0.56, p = 0.02, treatment mean 6.1 (±7.5) n=74, control mean 3.4 (±6.1) n=73, CFS.
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relative improvement, 81.8% better, RR 0.18, p < 0.001, treatment mean 6.6 (±10.5) n=74, control mean 1.2 (±7.4) n=73, SWS.
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relative improvement, 63.6% better, RR 0.36, p = 0.02, treatment mean 1.1 (±2.0) n=74, control mean 0.4 (±1.5) n=73, CSS.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Thomas et al., 22 Mar 2022, Double Blind Randomized Controlled Trial, placebo-controlled, United Kingdom, peer-reviewed, 7 authors, study period May 2020 - May 2021, this trial uses multiple treatments in the treatment arm (combined with bioflavonoids, chamomile, ellagic acid, resveratrol) - results of individual treatments may vary, Phyto-V trial.
Contact:
robert.thomas@bedfordhospital.nhs.uk (corresponding author), madeleine.williams@bedfordhospital.nhs.uk, yuuki.yanagisawa@bedfordhospital.nhs.uk, rajeev.kumar@bedordhospital.nhs.uk, jeffrey.aldous@beds.ac.uk, angel.chater@beds.ac.uk, rf451@cam.ac.uk.
Abstract: Article
A Randomised, Double-Blind, Placebo-Controlled Trial
Evaluating Concentrated Phytochemical-Rich Nutritional
Capsule in Addition to a Probiotic Capsule on Clinical
Outcomes among Individuals with COVID-19—The UK
Phyto-V Study
Robert Thomas 1,2, * , Madeleine Williams 1 , Jeffrey Aldous 3 , Yuuki Yanagisawa 1 , Rajeev Kumar 1 ,
Rachel Forsyth 4 and Angel Chater 3
1
2
3
4
*
Citation: Thomas, R.; Williams, M.;
Aldous, J.; Yanagisawa, Y.; Kumar, R.;
Forsyth, R.; Chater, A. A Randomised,
Double-Blind, Placebo-Controlled
Trial Evaluating Concentrated
Phytochemical-Rich Nutritional
Capsule in Addition to a Probiotic
Capsule on Clinical Outcomes among
Individuals with COVID-19—The UK
Phyto-V Study. COVID 2022, 2,
433–449. https://doi.org/10.3390/
covid2040031
Academic Editor: Simone Brogi
Received: 5 February 2022
Accepted: 17 March 2022
Published: 22 March 2022
Publisher’s Note: MDPI stays neutral
with regard to jurisdictional claims in
Bedfordshire Hospitals NHS Trusts, Bedford Hospital, Kempston Road, Bedford MK42 9DJ, UK;
madeleine.williams@bedfordhospital.nhs.uk (M.W.); yuuki.yanagisawa@bedfordhospital.nhs.uk (Y.Y.);
rajeev.kumar@bedordhospital.nhs.uk (R.K.)
Addenbrooke’s Cambridge University Hospitals NHS Trusts, Hills Road, Cambridge CB2 0QQ, UK
Institute of Sport and Physical Activity Research (ISPAR), Bedford Campus, University of Bedfordshire,
Polhill Avenue, Bedford MK41 9EA, UK; jeffrey.aldous@beds.ac.uk (J.A.); angel.chater@beds.ac.uk (A.C.)
Department of English, The Old Schools, Trinity Lane, Cambridge University, Cambridge CB2 1TN, UK;
rf451@cam.ac.uk
Correspondence: robert.thomas@bedfordhospital.nhs.uk; Tel.: +44-(0)1234-795787 or +44-(0)7715-110919
Abstract: Gut microflora dysbiosis affects the majority of individuals after COVID-19, contributing
to both gastro-intestinal (GI) and non-GI symptoms. Natural phytochemicals have reported anti-viral
properties and favourable effects on inflammatory and oxidative pathways, both important for tissue
damage post-viral pneumonia. This study involved 147 participants with symptomatic COVID-19,
randomised to receive a placebo (P) or a phytochemical-rich concentrated food capsule (PC) in
addition to a pre/probiotic lactobacillus capsule. Participants taking the PC had an almost two-fold
reduction in mean fatigue scores compared to P [p = 0.02], a three-fold reduction in cough score and
more than a double improvement in overall well-being scores [p = 0.02]. Two (1.5%) participants
reported mild, increased bloating which they felt was attributable to the capsules, although GI
symptoms improved in 25 of 31 participants (82%) who reported them at baseline. Sedentary, older,
previously hospitalised men with GI symptoms had a statistically significantly improvement among
those given the probiotic. Although some participants with early disease would have improved
spontaneously, such a rapid improvement observed in the majority of participants, who had been
suffering for an average of 108 days, was clinically relevant and welcomed, especially among those
more likely to have pre-existing gut dysbiosis. We are now evaluating whether this blend could also
enhance antibody titres post-COVID-19 vaccination.
Keywords: probiotic; COVID-19; gut-health; long-COVID-19
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