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Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS
Sponsor: Neuromed IRCCS
Summary
Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Although many advances have been made in MS treatment, the development of effective strategies for managing disease progression driven by excitotoxic synaptic dysfunctions is of great significance. Gut dysbiosis is commonly associated with both MS and obesity and high-fat diet (HFD) can exacerbate disease by acting on gut microbiota. Since gut microbiota can shape the immune response and brain functions, we propose to target gut dysbiosis by dietary supplementation of prebiotics and probiotics (Pre-Pro) to treat synaptopathy in both human and experimental model of MS, even when exacerbated by HFD. Overall, this project aims at unveiling the anti-inflammatory and neuroprotective pathways activated by Pre-Pro supplementation to modulate the immune-synaptic axis.
Official title: Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-07-26
Completion Date
2026-05-01
Last Updated
2023-08-14
Healthy Volunteers
No
Conditions
Interventions
Prebiotics and Probiotics supplementation
From the 1st day to the 15th day (included) patients with MS in the Pre-Pro group will receive daily: 1 capsule of Probactiol Duo, Metagenics (6 billions of Saccharomyces boulardii and 8,5 billions of probiotics including Bifidobacterium lactis Bi-07®, Bifidobacterium lactis Bl-04, Lacticaseibacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM®) 1. packet of Probactiol Stips, Metagenics (4 g inulin enriched with oligofructose) From the16th day to the 365th day (included) patients with MS in the Pre-Pro group will receive daily: 2. capsules of Probactiol HMO Combi, Metagenics (7,5 billions of Lactobacillus acidophilus NCFM®, 7,5 billions of Bifidobacterium lactis Bi-07®, 2,5 ug Vitamine D3, 320 ug Vitamine A, 100 mg Threonine, 250 mg 2'-Fucosyllactose).
Placebo supplementation
1-year supplementation with two placebo capsules/day containing starch, the probiotic bacteria carrier.
peripheral blood withdrawal
40 ml of blood for the isolation of Peripheral Blood Cells (PBMCs) and T cells.
Transcranial Magnetic Stimulation (TMS)
Intermittent theta burst stimulation (iTBS) protocol
Locations (1)
IRCCS INM-Neuromed
Pozzilli, Isernia, Italy