100
Participants
Start Date
July 26, 2023
Primary Completion Date
November 2, 2024
Study Completion Date
May 1, 2026
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
RECRUITING
IRCCS INM-Neuromed, Pozzilli
I.R.C.C.S. Fondazione Santa Lucia
OTHER
Neuromed IRCCS
OTHER