Category: Parkinson’s Disease: Clinical Trials
Objective: In this study, we evaluated the effect of targeted fructoligosaccharide (FOS) therapy to restore the beneficial butyrate producer Faecalibacterium prausnitzii, one the most highly reduced beneficial bacterial species in PD. We also evaluated if FOS improves constipation and gastrointestinal dysfunction.
Background: Consistent changes in the PD gut microbiome have been demonstrated in multiple studies. These include increased abundance of Akkermansia, Lactobacillus, and Bifidobacterium species in PD patients and is accompanied by a significant decrease in abundance of Prevotella, Faecalibacterium and Blautia species. The loss of beneficial butyrate producers and overgrowth of mucin degraders is a common theme in PD microbiomes.
Method: Patients with PD and functional constipation who met eligibility criteria, maintained stool diaries for at least 4 weeks and 3-day fluid and food diaries to ensure adequate hydration and fiber intake before enrolment. Patients took a proprietary mix of fructoligosaccharides (Livaux, 2400 mg) or matching placebo daily for 6 weeks with a washout period of at least 4 weeks between treatment periods. Patients completed bowel diaries, a Patient Assessment of Constipation Symptoms (PAC-Sym) questionnaire and took radio-opaque pellets daily during the 6th week of a treatment period followed by an abdominal x-ray to estimate colonic transit time. Stool, blood and serum biomarker samples were collected at the beginning and end of each treatment period to assess bacterial populations, microbiome metabolites and other biomarkers. Completed Bowel Motions (CBM)/week was the primary end-point. Secondary endpoints included total, spontaneous and complete spontaneous BM, PAC-Sym score and colonic transit time.
Results: Twelve patients were randomised equally to start Livaux or placebo. There was no significant difference in CBM/week between Livaux and placebo treatment periods (2.2 v 2.2, difference 0.0, 95% CI -0.7 to 0.8, p=0.9). Of the secondary endpoints only spontaneous BM differed with more in the Livaux group (3.8 v 3.3, difference 0.5, 95%CI 0.0 to 1.0, p=0.047). There were no significant adverse events.
Conclusion: Treatment with Livaux, although well tolerated, did not significantly increase the relative abundance of Faecalibacterium prausnitzii or improve constipation in subjects with PD in this study.
To cite this abstract in AMA style:
J. O'Sullivan, N. Jayabalan, N. Birch, D. Mondhe, A. Lehn, R. Gordon, R. Adan. Therapeutic restoration of Faecalibacterium prausnitzii in Parkinson’s disease using targeted fructoligosaccharides: a double-blind, placebo-controlled, cross-over trial [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/therapeutic-restoration-of-faecalibacterium-prausnitzii-in-parkinsons-disease-using-targeted-fructoligosaccharides-a-double-blind-placebo-controlled-cross-over-trial/. Accessed October 6, 2024.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/therapeutic-restoration-of-faecalibacterium-prausnitzii-in-parkinsons-disease-using-targeted-fructoligosaccharides-a-double-blind-placebo-controlled-cross-over-trial/