NCT05573542Enrolling by invitation
Early Signs of Parkinsons Disease in IBS
Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome
Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 3 Oct 2022
- Start date
- 1 May 2023
- Primary completion date
- Oct 2027
- Lead sponsor
- Örebro University, Sweden
- Diseases
- Parkinson disease
- NCT number
- NCT05573542
What you commit to
- Study type: Observational
- Planned participants: 120
- From 1 May 2023 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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:
- 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 illness
- 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.
- 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.
Age
- Males or females aged 18-85
Other
- 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.
Who the study is looking for
- 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
Criteria the registry did not label
- Patients with Parkinson's disease
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Campus USÖ, Örebro University Coordinator of this site? Confirm its status | Örebro | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.