Early Signs of Parkinsons Disease in IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease Irritable Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Parkinson's

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

No interventions assigned to this group

Patients with irritable bowel syndrome

Individuals with IBS according to ROME IV criterias

No interventions assigned to this group

Healthy controls

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Confirmed diagnosis by neurologist
2. Males or females aged 45-85 years
3. Signed informed consent

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)
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

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes