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Clinical Trials in Sweden / NCT05573542
Enrolling by invitation Observational

Early Signs of Parkinsons Disease in IBS

NCT05573542 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2023-05-01
Last updated
2024-04-03

Condition(s) studied

Parkinson DiseaseIrritable Bowel Syndrome

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
Patients with Parkinson's disease Inclusion Criteria: 1. Confirmed diagnosis by neurologist 2. Males or females aged 45-85 years 3. Signed informed consent Exclusion Criteria: 1. Other confirmed GI diseases (such as inflammatory bowel diseases) 2. Concurrent or recent treatment with antibiotics (\< 12 weeks) 3. 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). 4. Diagnosis of major psychiatric or somatic disease other than PD. 5. Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment. 6. Epilepsy. 7. Cerebral bleeding or history of cerebral bleeding. 8. Pregnancy or breastfeeding (will be asked). 9. Claustrophobia. 10. Smoking or using tobacco including snuff. 11. Dominant left-hand. 12. Inoperated apparatus (e.g., pacemaker). 13. Aneurysm clips in the head. 14. Shunts in the head. 15. Grenade-splinter or metal-splinter in the body (e.g.,eyes). 16. Metal or electrodes in the body (e.g., temp-catheter, aortastent, cochleaimplant). 17. Comprehensive tooth-implants or prothesis. 18. Operated in the head. 19. Operated in the heart. 20. Swallowed a video-capsule. 21. Any other reason the investigator feels the subject is not suitable for participation in the study. Patients with IBS Inclusion Criteria: 1. Fulfilling ROME IV criteria upon recruitment 2. Minimum 5 year of IBS symptoms 3. Males or females aged 18-85 years 4. Signed informed consent Exclusion criteria: 1. Other confirmed GI diseases (such as inflammatory bowel diseases) or PD 2. Concurrent or recent treatment with antibiotics (\< 12 weeks). 3. 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: 1. Males or females aged 18-85 2. Signed informed consent Exclusion criteria: 1. Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (\< 12 weeks), antibiotics (\< 12 weeks) 2. No on going GI symptoms 3. 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). 4. Diagnosis of major psychiatric or somatic disease. 5. Abuse of alcohol or drugs according to Alcohol Use Disorders Identification Test (AUDIT), and/or clinical judgment. 6. Recent (\< 4 weeks) intake of proton pump inhibitors, PPI (e.g., omeprazol). 7. Epilepsy. 8. Cerebral bleeding or history of cerebral bleeding. 9. Pregnancy or breastfeeding (will be asked). 10. Claustrophobia. 11. Smoking or using tobacco including snuff. 12. 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. 22. Regular intake of anti-inflammatory medication (including NSAIDs). 23. Any other reason the investigator feels the subject is not suitable for participation in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Campus USÖ, Örebro University Örebro Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05573542 on ClinicalTrials.gov ↗ ← All trials in Sweden