The fourth and most important goal is to harmonize all of the above information for the purpose of designing clinical trials used to assess our ability to eliminate harmful bacteria and encourage beneficial bacteria.
We envisioned a clinical trial in which individuals would receive either a protective microbiota substance, or perhaps an antibiotic effective against a culprit bacteria.
Spearheaded by Associate Professor of Neurology Jeffrey Gelfand, MD, UCSF launched Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis: A Phase 1b Clinical Trial to Evaluate Feasibility, Safety, Tolerability and Effects on Immune Function in November 2018.
In this open-label prospective clinical trial, patients with relapsing-remitting MS disease type underwent FMT* of a donor stool called FMP30 via colonoscopy. This active phase of the study, which involved assessing immunological efficacy at specific timepoints, continued for 12 weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel observational control arm of MS patients who otherwise satisfy study inclusion criteria were recruited as a comparison observational group to measure stability of stool and serum immunological measures.
Read more here: https://clinicaltrials.ucsf.edu/trial/NCT03594487
*FMT involves the transfer of stool from a healthy donor to a recipient with a disease believed to be related to an unhealthy gut microbiome.