València, Spain—ADM and Hospital de Sagunto have announced a 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, according to a press release.

In March, the press release says, 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, a trend particularly prevalent in elderly patients.

A decision was made that an interventional trial should be conducted to evaluate the effects of standard medication on elderly COVID-19 patients, along with a live microbial supplement to help support gut health and immune function. The press release states that Dr. Cortés then contacted ADM’s scientific team for advice on which microbial strains to use, and to invite the team to collaborate with Hospital de Sagunto on the design of the trial.

It was determined that the trial would use Gasteel Plus, a supplement marketed by Laboratorios Heel España, S.A.U., formulated using ADM probiotic strains along with vitamin D, Selenium, and Zinc, the press release says. The product has been administered to patients with COVID-19 symptoms and to healthcare personnel at the hospital who fall into high-risk groups. The three ADM probiotic strains contained in Gasteel Plus, namelyBifidobacterium longumCECT7347,Bifidobacterium animalis subsp. lactisCECT9950 andLactobacillus 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, the release says.
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“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 in the release. “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.”

Francisco Climent, ADM’s Health & Wellness Managing Director, EMEAI, added: “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. 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.”