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

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 26, 2023

Primary Completion Date

November 2, 2024

Study Completion Date

May 1, 2026

Conditions
Patient Participation
Interventions
DIETARY_SUPPLEMENT

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)."

DIETARY_SUPPLEMENT

Placebo supplementation

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

PROCEDURE

peripheral blood withdrawal

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

PROCEDURE

Transcranial Magnetic Stimulation (TMS)

Intermittent theta burst stimulation (iTBS) protocol

Trial Locations (1)

86077

RECRUITING

IRCCS INM-Neuromed, Pozzilli

All Listed Sponsors
collaborator

I.R.C.C.S. Fondazione Santa Lucia

OTHER

lead

Neuromed IRCCS

OTHER