Category: Parkinson’s Disease: Clinical Trials
Objective: To evaluate the impact of fecal microbiome transplant (FMT) on disease progression as a secondary outcome of a safety study using PRIM-DJ2727 in Parkinson’s disease (PD).
Background: Abnormal microbiota contributes to α-synuclein aggregation in the autonomic nervous system causing intestinal inflammation and dysbiosis that eventually reaches the brainstem substantia nigra via transneuronal spread along the vagus nerve.
Method: 9-month single-center randomized placebo study. Twelve subjects with mild/moderate PD were randomly assigned 2:1 to receive either active PRIM-DJ2727 capsules (8 subjects) or Placebo capsules (4 subjects). Treatment was administered orally twice weekly for 12 weeks (total 24-doses). PD symptoms were evaluated at screening, 1 and 6 months post-treatment and involved four different domains: cognition and behavioral changes, motor function, disability, and quality of life.
Results: All patients sustained motor improvement when tested in the OFF state. One month after treatment, the FMT cohort had a mean reduction of 40% in UPDRS-Motor (p=0.03) and 36% in UPDRS-Total (p=0.02). Likewise, there was a self-reported improvement of constipation by Visual Analog Scale (p<0.0001), this finding persisted at 3 months. Conversely, there was no significant change for the GDS, PAS, NMS and PDQ-39 scores within the group. The Placebo arm also exhibited a reduction of UPDRS at one month, but this was not statistically significant. Over time, the between-group (FMT vs Placebo) comparison showed a significant positive effect of the FMT group on UPDRS-M (p=0.04) and UPDRS-T (p=0.009).
Conclusion: Total and motor subscales of the UPDRS exhibit a reduction at one-month post-PRIM-DJ2727 treatment. However, this was not sustained after 6 months. We hypothesize that to maintain the microbiome changes produced by the FMT treatment, a longer treatment period will be required, and a concomitant modification in the patient’s diet.
To cite this abstract in AMA style:
J. Suescun, M. Schiess, Z. Jiang, V. Thyne, T. Iqbal, N. Utay, M. Newmark, A. Dupont, A. Alexander, H. Dupont. Secondary endpoints of a randomized, placebo-Controlled Pilot Study to evaluate the safety of lyophilized PRIM-DJ2727 in Parkinson’s disease [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/secondary-endpoints-of-a-randomized-placebo-controlled-pilot-study-to-evaluate-the-safety-of-lyophilized-prim-dj2727-in-parkinsons-disease/. Accessed May 16, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/secondary-endpoints-of-a-randomized-placebo-controlled-pilot-study-to-evaluate-the-safety-of-lyophilized-prim-dj2727-in-parkinsons-disease/