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Enrolling by invitation NCT05573542

Early Signs of Parkinsons Disease in IBS

— Observational Parkinson Disease Irritable Bowel Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease, Irritable Bowel Syndrome. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome

Overview

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.

Detailed description

All study participants will give 3 study visits and questionnaires and faecal collection kits will be sent to them before the first visit.

Visit 1: Study participants will undergo a sigmoidoscopy during which the researchers will collect 16 biopies. Twelve of the biopsies goes to ussing chamber studies of permeability while the remaining biopsies will be alliqoted for ultrastructural characterisation, alpha-synuclein aggregation assay and immunoflourescence. Blood samples will be drawn from the participants at this visits for metabolomic studies and platelet aggregation potential. In addition, study participants will also bring filled out questionnaires and faecal samples (microbiota analysis).

Visit 2: Study participants will undergo a functional magnetic resonance imaging session for analysis of brain function. This visit will last for approximately 1 hour (preparations included).

Visit 3: Participants will come in for a final sigmoidoscopy where the biopsies will be collected exclusively for performing the immuno-neurophenotyping of lamina propria lymphocytes.

Primary outcome measures

  • Presence of alpha-synuclein [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
Secondary outcome measures (12)
  • Intestinal permeability [Time frame: 1 day]
  • Mucosal ultrastructure: cell activation [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
  • Mucosal ultrastructure: cell-to-cell interaction [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
  • Microbiota composition [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
  • Metabolomics [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
  • Brain function [Time frame: 1day]
  • Aggregation potential of alpha-synuclein [Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project]
  • Platelet aggregation [Time frame: 1 day]
  • Immunophenotyping [Time frame: 1 day]
  • Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome version (GSRS-IBS) [Time frame: 1 day]
  • Irritable bowel syndrome- symptom severity scale (IBS-SSS) [Time frame: 1 day]
  • Food Frequency Questionnaire (FFQ) [Time frame: 1 day]

Eligibility criteria

Patients with Parkinson's disease

Inclusion criteria

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

Exclusion criteria

  • 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).
  • Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).
  • Comprehensive tooth-implants or prothesis.
  • Operated in the head.
  • Operated in the heart.
  • Swallowed a video-capsule.
  • Any other reason the investigator feels the subject is not suitable for participation in the study.

Patients with IBS

Inclusion criteria

  • Fulfilling ROME IV criteria upon recruitment
  • Minimum 5 year of IBS symptoms
  • Males or females aged 18-85 years
  • Signed informed consent

Exclusion criteria

  • Other confirmed GI diseases (such as inflammatory bowel diseases) or PD
  • 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).

3\) Diagnosis of major psychiatric or somatic disease. 4) Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.

5\) Epilepsy. 6) Cerebral bleeding or history of cerebral bleeding. 7) Pregnancy or breastfeeding (will be asked). 8) Claustrophobia. 9) Smoking or using tobacco including snuff. 10) Dominant left-hand. 13) Inoperated apparatus (e.g., pacemaker). 14) Aneurysm clips in the head. 15) Shunts in the head. 16) Grenade-splinter or metal-splinter in the body (e.g.,eyes). 17) Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).

18\) Comprehensive tooth-implants or prothesis. 19) Operated in the head. 20) Operated in the heart. 21) Swallowed a video-capsule. 25) Any other reason the investigator feels the subject is not suitable for participation in the study.

Healthy controls:

Inclusions criteria:

  • Males or females aged 18-85
  • Signed informed consent

Exclusion criteria

  • Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), antibiotics (< 12 weeks)
  • No on going GI symptoms
  • 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.
  • Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment.
  • Recent (< 4 weeks) intake of proton pump inhibitors, PPI (e.g., omeprazol).
  • 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).
  • Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant).
  • Comprehensive tooth-implants or prothesis.
  • Operated in the head.
  • Operated in the heart.
  • Swallowed a video-capsule.
  • Regular intake of anti-inflammatory medication (including NSAIDs).
  • Any other reason the investigator feels the subject is not suitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Campus USÖ, Örebro University — Örebro

Identifiers

NCT: NCT05573542 · PARKIBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗