Studying bowel tissue for early signs of Parkinson's in irritable bowel syndrome
Compares gut tissue from people with irritable bowel syndrome, Parkinson's disease and healthy controls.
Plain-language title generated from the registry record
Registry title: Early Signs of Parkinsons Disease in IBS
Key facts
- Where
- Örebro, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05573542, who can take part
Where in Sweden
- Campus USÖ, Örebro UniversityÖrebro, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Örebro University, Sweden
- Trial code
- NCT05573542
- Record updated
- 3 April 2024
- Original description
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.Read full original descriptionShow less
Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome
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.
Inclusion: Confirmed diagnosis by neurologist; Males or females aged 45-85 years; Signed informed consent; Fulfilling ROME IV criteria upon recruitment; Minimum 5 year of IBS symptoms; Males or females aged 18-85 years; Signed informed consent.
Exclusion: 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); Comprehensive tooth-implants or prothesis; 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); Concurrent or recent treatment with drugs affecting intestinal microbiota, function or mood, e.g., antidepressants (< 12 weeks), 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); Recent (< 4 weeks) intake of proton pump inhibitors, PPI (e.g., omeprazol); Comprehensive tooth-implants or prothesis; Regular intake of anti-inflammatory medication (including NSAIDs); Other confirmed GI diseases (such as inflammatory bowel diseases); 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; Operated in the heart; Other confirmed GI diseases (such as inflammatory bowel diseases) or PD; 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; 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); 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:; Diagnosis of major psychiatric or somatic disease; 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; Operated in the heart; Males or females aged 18-85; 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); Operated in the head; Swallowed a video-capsule; Any other reason the investigator feels the subject is not suitable for participation in the study; Patients with IBS; Signed informed consent; No on going GI symptoms; 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); Operated in the head; Swallowed a video-capsule; Any other reason the investigator feels the subject is not suitable for participation in the study.
Patients with Parkinson's disease.