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Early Signs of Parkinsons Disease in IBS

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

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  1. Minor Start date changed from estimate of May 2023 to May 1, 2023v3
  2. Notable Start date: Oct 2022 to May 2023
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    • Collaborators revised (3)
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bowel symptoms like constipation and abdominal pain are characteristic symptoms of irritable bowel syndrome (IBS). The pathogenesis and pathophysiology are not fully understood but subject to intense research, with emphasis on aberrations in the gut-brain axis, low-grade inflammation and gut barrier dysfunction that results in increased permeability and microbial translocation. Many patients with Parkinson's disease (PD) have reported bowel symptoms similar to that in IBS patients decades prior to the diagnosis of PD. Epidemiological studies show a significantly elevated risk of developing PD in IBS patients, though there is no knowledge on a pathogenic connection between these disorders. Recent studies show increased gut permeability and intestinal presence of pathological alpha-synuclein aggregates, the neuropathological hallmark in PD, indicating the involvement of the gut-brain axis. We aim to compare the presence of colonic alpha-synuclein between IBS, PD patients and healthy controls to relate these findings to intestinal permeability, ultrastructural mucosal changes, immune cell interactions, microbiota composition and brain function. This project could identify IBS groups at risk of developing PD and birth the development of early clinical diagnostic methods.
Trial Details
NCT Number NCT05573542
Lead Sponsor Örebro University, Sweden
Collaborators: VHIR, Aston University, Region Örebro County
Conditions
(from sponsor)
Parkinson Disease, Irritable Bowel Syndrome
Related terms Irritable Bowel Syndrome, Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov