ADM) and Hospital de Sagunto, one of the largest medical centers in the Valencia region, today announce their partnership for a clinical trial into the effects of using a food supplement containing live microbial strains to promote gut microbiome balance and help improve health functions related to outcomes for COVID-19 patients in high-risk groups.
On 18th March Dr Xavier Cortés, gastroenterologist at Hospital de Sagunto, communicated with medical staff in China who had observed that many COVID-19 patients had exhibited abnormal changes in their gut microbiome. The reports indicated that a significant percentage of infected people experienced gastrointestinal problems in the early stages of the illness, similar to the trend he was observing in Spain. This trend is particularly prevalent in elderly patients, who tend to have lower levels of beneficial bifidobacterial content in their gut microbiome. Following his assessment, a decision was made that an interventional trial should be conducted to evaluate the effects of providing standard medication to elderly COVID- 19 patients, along with a live microbial supplement to help support gut health and immune function. Dr Cortés contacted ADM’s scientific team for expert advice on the most potentially suitable live microbial strains to use during the trial, and to invite the team to collaborate with Hospital de Sagunto in the design of the clinical trial.
Gasteel Plus, a live microbial probiotic-based food supplement marketed by Laboratorios Heel España, S.A.U. and formulated using ADM probiotic strains, as well as essential nutrients vitamin D, selenium and zinc, was selected in this interventional trial. The product has been administered to patients with COVID-19 symptoms, as well as to healthcare personnel at the hospital who fall into high-risk groups (the over 60s or those with chronic diseases), at Hospital de Sagunto, to strengthen their gut microbiota. The three ADM probiotic strains contained in Gasteel Plus, namely Bifidobacterium longum CECT7347, Bifidobacterium animalis subsp. lactis CECT9950 and Lactobacillus rhamnosus CNCM-I4036, as well as essential nutrients vitamin D, selenium and zinc, have been shown in pre-clinical studies to exert anti-inflammatory, antioxidant and other immune-supporting effects.
“Thanks to the common efforts of three teams from the Hospital de Sagunto, Heel Laboratories and ADM Biopolis, we were able to start the trial at the end of March and we are discovering innovative solutions to challenging health and wellness concerns.” said Francisco Climent, ADM’s Health & Wellness managing director, EMEAI.
“More than 75 patients admitted to the hospital with COVID-19 have already been enrolled in the trial, and are giving regular blood, stool, urine and nasopharyngeal exudate samples to measure changes in immune parameters and other factors such as viral load,” said Dr. Cortés. “Using these indicators, we will assess the efficacy of Gasteel Plus as an adjunct solution to support the health of the elderly population, who are especially vulnerable to this viral infection.”
“In the coming weeks, we aim to expand the reach of this study to 100 patients, while simultaneously exploring the potential beneficial effects of additional ingredients such as botanical extracts, oils and fibers in separate pre-clinical studies,” Climent continued. “Through this research, we hope to create more unique blends of our health and wellness ingredients that may help support the health of those for whom COVID-19 poses the greatest threat.”
ADM is a leader in developing probiotic solutions and its products have been recognized by multiple award wins, most recently in the NutraIngredients Awards 2020. The awards saw ADM’s Bio-Kult Migréa® win Probiotic Product of the Year for its role in migraine management and its Bifidobacterium lactis BPL1 win in the Ingredient of the Year: Weight Management category. A third award, the Editor’s Award for Functional Food Innovation, went to Bacillus subtilis PXN®21®, a live bacteria strain shown to reduce the aggregation of α-synuclein, the protein that causes Parkinson’s disease.