Myalgic encephalomyelitis (ME), also called chronic fatigue syndrome (CFS), is a debilitating disease which presents as unexplained persistent fatigue. Sufferers experience muscle and/or joint pain, headaches, anxiety and depression, and post-exertional malaise. Often unrecognised by healthcare systems and with no treatment options, patients rely on family support. Through the Help4ME project, ImmuneBiotech Medical Sweden has developed GutMagnific®. This is a five-strain lactobacilli probiotic food supplement designed to counter the biological mechanisms responsible for irritable bowel syndrome (IBS) alone, or as it co-exists with other conditions, such as ME. GutMagnific® provokes pathogen inhibition and anti-inflammatory action, and normalises gut permeability, reducing bacteria leaking into the bloodstream. EU support enabled the team to collect input from individual ME patients who had been using GutMagnific®. These case studies have furnished positive initial data. There is an improvement in all IBS symptoms, and for ME sufferers a major improvement in energy shortage/severe fatigue, ‘brain fog’ and sleep disturbance. Users also reported a positive impact on post-exertional malaise and a minor improvement in pain (joints and headache). The results have enabled the team to prepare a forthcoming randomised study with 90 patients in three groups, testing GutMagnific® in two doses and placebo, over 3 months, with a month’s follow up. The first national patent has been granted in South Africa and is pending in 12 territories, with GutMagnific® a registered trade mark in Europe, and pending registration in the United States and China. It is currently available on the dedicated GutMagnific web shop. The team is gathering customer feedback and planning to scale up their e-commerce.
The link between the gut and ME
The human intestine is colonised by an estimated 100 trillion bacteria (the microbiota), which have co-evolved in a symbiotic relationship – an estimated 1 000 microbial species inhabit a healthy microbiota. However, antibiotic use, C-section delivery and lifestyle factors, such as food habits and high stress levels, often disrupt the balance, causing dysbiosis. Increasingly, science is investigating how this might influence a range of immune system, autonomic nervous system and brain disorders. Dysbiosis is known to be linked to ME, for example with elevated pathogens (e.g. high level of E. coli), and small intestinal bacterial overgrowth (SIBO). Since 35-90 % of ME patients also suffer from IBS, the hypothesis of the upcoming clinical trial is that if IBS can be ameliorated by GutMagnific®, then the ME symptoms could also be improved. “With GutMagnific® we are conceiving a new probiotic category of products designed with pharmaceutical precision, where the starting point is the specific condition, not the probiotic strain!” says Karin Larsson ImmuneBiotech Chief Business Officer.
Meeting the needs of an unserved population
Despite affecting more people than multiple sclerosis, lupus and many forms of cancer, ME gets very little research funding. As a relatively ‘new’ disease with scant medical support, its prevalence is hard to determine but has been estimated at 17-24 million. The disease affects three times more women than men and often presents in the 40s-50s or adolescence. With recovery rates very low, the cost to healthcare systems is enormous. After analysing the clinical study results, the team will develop an ME-specific product, as well as conduct larger multicentre clinical studies before scaling the business internationally. “GutMagnific® could also be an effective treatment for other gut-related conditions, such as Clostridium difficile infection, and has potential for conditions co-existing with IBS, such as fibromyalgia or multiple sclerosis,” says Larsson.
Help4ME, gut, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Irritable Bowel Syndrome, microbiota, bacteria, dysbiosis, immune system, autonomic nervous system, brain disorders