Early Signs of Parkinsons Disease in IBS

NCT05573542 | Enrolling By Invitation

• 1 other identifier: PARKIBS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Irritable Bowel Syndrome

Keywords

Alpha-synuclein; Intestinal permeability; Gut-brain axis; Mucosal ultrastructure; Brain function; Microbiota; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Presence of alpha-synuclein

  Alpha-synuclein is the hallmark protein of Parkinson's disease and the presence of this protein will be detected with immunoflourescence in colonic tissues

  Stored samples collected from a one day visit will be continously analysed during the 5 year project

Secondary Outcomes (18)

• Intestinal permeability

  1 day

• Mucosal ultrastructure: cell activation

  Stored samples collected from a one day visit will be continously analysed during the 5 year project

• Mucosal ultrastructure: cell-to-cell interaction

  Stored samples collected from a one day visit will be continously analysed during the 5 year project

• Microbiota composition

  Stored samples collected from a one day visit will be continously analysed during the 5 year project

• Metabolomics

  Stored samples collected from a one day visit will be continously analysed during the 5 year project

Study Arms (3)

Patients with Parkinson's

Individuals with confirmed diagnosis of Parkinson's disease by neurologist.

Patients with irritable bowel syndrome

Individuals with IBS according to ROME IV criterias

Healthy controls

Healthy individuals lacking both IBS and Parkinson's disease, in addition to other criteras stated in the Eligibility section.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parkinson patients will be recruited from the neurological department at Örebro University hospital by neurologist. Patients with IBS will be recruited from the gastroenterology deparments at Örebro University hospital by gastroenterologist. Healthy controls will be recruited via local advertisements or from previous study pools.

You may qualify if:

• Confirmed diagnosis by neurologist
• Males or females aged 45-85 years
• Signed informed consent

You may not qualify if:

• Other confirmed GI diseases (such as inflammatory bowel diseases)
• Concurrent or recent treatment with antibiotics (\< 12 weeks)
• Concurrent or recent (\< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort and probiotics/prebiotics).
• Diagnosis of major psychiatric or somatic disease other than PD.
• Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.
• Epilepsy.
• Cerebral bleeding or history of cerebral bleeding.
• Pregnancy or breastfeeding (will be asked).
• Claustrophobia.
• Smoking or using tobacco including snuff.
• Dominant left-hand.
• Inoperated apparatus (e.g., pacemaker).
• Aneurysm clips in the head.
• Shunts in the head.
• Grenade-splinter or metal-splinter in the body (e.g.,eyes).

Sponsors & Collaborators

• Örebro University, Sweden: lead
• VHIR: collaborator
• Aston University: collaborator
• Region Örebro County: collaborator

Study Sites (1)

Campus USÖ, Örebro University

Örebro, 70362, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease; Irritable Bowel Syndrome; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robert J Brummer, PhD/MD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)