RecruitingNot ApplicableNCT05779449

Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS

Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in Multiple Sclerosis

Sponsor

Neuromed IRCCS

Enrollment

100 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Patient Participation

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether changing the gut microbiome (the bacteria living in your intestines) through diet can reduce brain inflammation in people with relapsing-remitting multiple sclerosis (MS). Researchers believe an imbalance in gut bacteria may contribute to a type of nerve damage in MS, and they want to test whether a specific diet can correct this. **You may be eligible if:** - You have a diagnosis of relapsing-remitting MS - You are between 18 and 65 years old - Your disability level is moderate or below (EDSS score ≤7) - You have had MS for less than 10 years - You are on a stable MS medication (dimethyl fumarate or ocrelizumab) for at least 3 months - You have not taken corticosteroids in the past month **You may NOT be eligible if:** - You are allergic to gadolinium contrast agent used in MRI scans - You have abnormal blood counts - You are pregnant or breastfeeding - You are vegetarian or vegan - You have taken antibiotics, probiotics, omega-3, or antioxidant supplements in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPrebiotics 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).

DIETARY_SUPPLEMENTPlacebo supplementation

1-year supplementation with two placebo capsules/day containing starch, the probiotic bacteria carrier.

PROCEDUREperipheral blood withdrawal

40 ml of blood for the isolation of Peripheral Blood Cells (PBMCs) and T cells.

PROCEDURETranscranial Magnetic Stimulation (TMS)

Intermittent theta burst stimulation (iTBS) protocol