Microbiome is a subject close to my heart. It consumes a larger part of the research budgets and there are loads of places doing trials and this is the phase I report of a trial. It says “Microbial composition, richness and diversity did not change after feacal microbiome transplant”. Surely this is the point of feacal transplants and whilst this study says the procedure is relatively safe. Anyway phase II & III here we come
Abstract Number: 1693/P298
Fecal microbiota transplantation in patients with multiple sclerosis, a phase I study Fecal microbiota transplantation in patients with multiple sclerosis, a phase I study Rogier Ooijevaar et al.
Objectives/Aims: The gut microbiome has been implicated in the pathogenesis and disease progression of MS. Modulating the microbiota through fecal microbiota transplantation (FMT) could provide a novel therapeutic approach for MS. Objectives/Aims: The primary objective in this pilot study was to assess the safety of FMT in MS patients. Secondary objectives included evaluating changes in microbiota, inflammatory markers (neurofilament light [NfL], cytokines, lipid mediators [LM]), and clinical parameters like the expanded disability status scale (EDSS)
Methods: Ten patients with different forms of MS (relapse remitting MS n=3, primary progressive MS n=3, secondary progressive MS n=4) received FMT twice from a single rigorously screened healthy donor. FMT was administered via a nasoduodenal tube after pretreatment with vancomycin and bowel lavage before the first FMT. MRI scans were performed at enrolment and at the end of the study. EDSS was assessed throughout the study. Fecal and blood samples were collected for microbiota and inflammatory marker analysis, respectively. Samples were taken at baseline, one week, four weeks, and 6 months following the last FMT. Microbiota composition, richness and diversity of donor and patients were determined through 16S rRNA amplicon sequencing analysis of fecal samples, while NfL levels and cytokines were measured in serum plasma. Lipidomics analysis was performed on plasma. The total follow-up was six months.
Results: No serious adverse events occurred other than one participant, who had active MRI findings before and after FMT, and experienced a clinical relapse. Most adverse events were mild, transient and procedure-related. The patients’ microbiota composition became more similar one week after FMT, but overall was significantly different from the donors (Permanova, P = 0.001). Moreover, microbial richness and diversity did not change after FMT. EDSS scores improved in four patients, remained stable in four, and worsened in two patients. NfL levels, remained stable between baseline and follow-up in all patients (median NfL 8.70 pg/ml at baseline vs. 9.90 pg/ml at week 24 post-FMT, p = 0.30). Among cytokines, only MCP-1 showed a significant change over time with initially lower values compared to baseline. Additionally, lipid mediators involved in the initiation and resolution of inflammation, such as arachidonic acid-derived LMs, were altered longitudinally.
Conclusion: FMT was safe in ten MS patients in this phase I study with six months of follow-up. Microbial composition, richness and diversity did not change after FMT. Subtle changes in systemic immune response to FMT were observed. A larger study with extended follow-up is needed to elucidate the potential benefits of FMT in MS patients.
Source: multiple-sclerosis-research.org