Clinical Trial

Early Signs of Parkinsons Disease in IBS

Enrolling by Invitation
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-10-05; most recent amendment 2024-04-02.
Status change: Recruiting → Enrolling by Invitation 2023-03-21
Trial Details
NCT Number NCT05573542
Lead Sponsor Örebro University, Sweden
Collaborators: VHIR, Aston University, Region Örebro County
Conditions Parkinson Disease, Irritable Bowel Syndrome
Enrollment 120 participants
Start Date 2023-05-01
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2024-04-03