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

Launched by NEUROMED IRCCS · Mar 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people with multiple sclerosis (MS) by focusing on the health of the gut. Researchers believe that an imbalance in gut bacteria, known as gut dysbiosis, can worsen inflammation and nerve damage in MS. By using dietary supplements called prebiotics and probiotics, which help to restore healthy gut bacteria, the trial aims to see if this approach can improve symptoms related to nerve damage, even for those who may have an unhealthy diet.

To participate in this study, you need to be between 18 and 65 years old and have been diagnosed with relapsing-remitting MS. You should also be currently taking specific medications for MS and have not taken certain other treatments recently. If you join the trial, you can expect to receive either the prebiotic and probiotic supplements or a placebo (a non-active version) while being closely monitored for any changes in your health. The trial is open to all genders and is currently recruiting participants. If you or a family member is interested, it’s a chance to contribute to research that could lead to better treatments for MS.

Gender

ALL

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.