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NCT05779449: Pre-Pro-MS
Targeting the Gut Dysbiosis to Treat Inflammation-driven Synaptopathy in MS
NA trial testing Prebiotics and Probiotics supplementation in Patient Participation in 100 participants. Currently enrolling.
2 November 2024
Quick facts
| Lead sponsor | Neuromed IRCCS |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 26 July 2023 |
| Primary completion | 2 November 2024 |
| Estimated completion | 1 May 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Prebiotics and Probiotics supplementation
- Placebo supplementation
- peripheral blood withdrawal
- Transcranial Magnetic Stimulation (TMS)
Conditions studied
- Patient Participation — all drugs for Patient Participation →
Sponsor
Neuromed IRCCS
Who can join
Adults 18 to 65, any sex, with Patient Participation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inflammatory synaptopathy is a prominent pathogenic process in multiple sclerosis (MS) induced by imbalanced immune system homeostasis. Its persistence causes excitotoxic neuronal damage, leading to motor and cognitive deficits. Although many advances have been made in MS treatment, the development of effective strategies for managing disease progression driven by excitotoxic synaptic dysfunctions is of great significance. Gut dysbiosis is commonly associated with both MS and obesity and high-fat diet (HFD) can exacerbate disease by acting on gut microbiota. Since gut microbiota can shape the immune response and brain functions, we propose to target gut dysbiosis by dietary supplementation of prebiotics and probiotics (Pre-Pro) to treat synaptopathy in both human and experimental model of MS, even when exacerbated by HFD. Overall, this project aims at unveiling the anti-inflammatory and neuroprotective pathways activated by Pre-Pro supplementation to modulate the immune-synaptic axis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05779449
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05779449 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neuromed IRCCS
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05779449.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing