Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS (Pre-Pro-MS)
Patient Participation
About this trial
This is an interventional treatment trial for Patient Participation focused on measuring gut microbiota, dysbiosis, multiple sclerosis, glutamate-mediated excitotoxicity, synaptopathy
Eligibility Criteria
Inclusion Criteria: RRMS diagnosis, as Polman et al 2011. Ann Neurol. PMID: 21387374 Age <= 18 and => 65 years EDSS score <= 7 Disease duration < 10 years On DMF or Ocrelizumab treatment from at least 3 months No corticosteroid administration in the previous month Ability to provide written informed consent. Exclusion Criteria: Adverse effects to gadolinium Blood count basal alteration Pregnant or lactating women Vegetarians or vegans Taking antibiotics, any product or supplement containing probiotics, Omega 3 or other antioxidant supplements within 30 days prior to inclusion History of food allergies or food intolerance Clinically significant medical condition other than MS, (latent infections, other autoimmune disease) Diagnosis of past eating disorders (anorexia, bulimia, or binge eating) or relevant psychiatric disorders.
Sites / Locations
- IRCCS INM-NeuromedRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pre-Pro group
Placebo group
Patients with RRMS under dimethyl fumarate or Ocrelizumab treatment according to the good clinical practice, who will recieve the following dietary supplementation with pre- and probiotics: 1st-15th days: One capsule containg 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® (Probactiol Duo cps, Metagenics) One packet with 4 g of prebiotics including inulin enriched with oligofructose (Probactiol Stips bustine Metagenics). 16th-365th days: Two capsules, each containg 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 (Probactiol HMO Combi cps, Metagenics).
Patients with RRMS under dimethyl fumarate or Ocrelizumab treatment according to the good clinical practice, who will receive only starch, the probiotic bacteria carrier: 1st-15th days: One capsule and one packet only with starch. 16th-365th days: Two capsules containg starch.