Targeting gut health to treat inflammation in multiple sclerosis
Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in Multiple Sclerosis
This study is testing if adding prebiotics and probiotics to the diet can help reduce inflammation and protect the brain in people with multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neuromed IRCCS Academic / other |
| Drugs / interventions | Ocrelizumab |
| Locations | 1 site (Pozzilli, Isernia) |
| Trial ID | NCT05779449 on ClinicalTrials.gov |
What this trial studies
This study aims to address inflammation-driven synaptopathy in multiple sclerosis (MS) by targeting gut dysbiosis through dietary supplementation of prebiotics and probiotics. The approach is based on the understanding that gut microbiota can influence immune responses and brain functions, which are critical in MS pathology. Participants will receive either the Pre-Pro supplementation or a placebo, and their responses will be monitored to evaluate the anti-inflammatory and neuroprotective effects of the treatment. The study also includes peripheral blood withdrawal and Transcranial Magnetic Stimulation (TMS) to assess the underlying mechanisms of synaptopathy in MS.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with relapsing-remitting multiple sclerosis aged between 18 and 65 years, with a disease duration of less than 10 years.
Not a fit: Patients with significant comorbidities, recent corticosteroid use, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention to mitigate inflammation and improve neurological function in MS patients.
How similar studies have performed: While the specific approach of targeting gut dysbiosis in MS is novel, there is emerging evidence suggesting that gut microbiota modulation can positively influence autoimmune conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pozzilli, Isernia
- IRCCS INM-Neuromed — Pozzilli, Isernia, Italy (Recruiting)
Study contacts
- Study coordinator: Silvia Caioli, MD
- Email: silviacaioli@yahoo.it
- Phone: +39 3332790061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.