Parkinson DiseaseNCT05573542
Early Signs of Parkinsons Disease in IBS
An observational study of Parkinson Disease and Irritable Bowel Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Irritable Bowel Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2023to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson patients will be recruited from the neurological department at Örebro University hospital by neurologist. Patients with IBS will be recruited from the gastroenterology deparments at Örebro University hospital by gastroenterologist. Healthy controls will be recruited via local advertisements or from previous study pools.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 55Show fewer
- 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
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Irritable Bowel Syndrome
- Keywords
- Alpha-synuclein, Intestinal permeability, Gut-brain axis, Mucosal ultrastructure, Brain function, Microbiota, Metabolomics
- Medical subject headings
- Parkinson Disease, Irritable Bowel Syndrome, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's | Individuals with confirmed diagnosis of Parkinson's disease by neurologist. | |
| Patients with irritable bowel syndrome | Individuals with IBS according to ROME IV criterias | |
| Healthy controls | Healthy individuals lacking both IBS and Parkinson's disease, in addition to other criteras stated in the Eligibility section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of alpha-synuclein
Alpha-synuclein is the hallmark protein of Parkinson's disease and the presence of this protein will be detected with immunoflourescence in colonic tissues
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Secondary outcomes (18)
Intestinal permeability
Colonic permeability measured by biopsies mounted in Ussing chambers
Measured: 1 day
Mucosal ultrastructure: cell activation
Morphologic quantification of cell size and granule density using Electron microscopy
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Mucosal ultrastructure: cell-to-cell interaction
Quantitative measurement of distance between cells to interpolate cell-to-cell interaction using Electron microscopy
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Microbiota composition
Analysis of faecal microbiota composition and function (metagenomics)
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Metabolomics
Metabolomic analysis of inflammatory markers, sex hormones and enviromental pollutants in blood and faeces
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Brain function
Structural and functional alterations in the brain and brainstem using functional magnetic resonance imaging
Measured: 1day
Aggregation potential of alpha-synuclein
Measure the potential of alpha-synuclein to form aggregates in colonic biopsies
Measured: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Platelet aggregation
Platelets will be isolated from blood samples and run on an aggregometer to elcuidate platelet aggregation potential
Measured: 1 day
Immunophenotyping
Lamina propria lymphocytes will be characterised for their immune-neurophenotype using flow cytometry
Measured: 1 day
Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome version (GSRS-IBS)
The Gastrointestinal Symptoms Rating Scale (GSRS) evaluates gastrointestinal (GI) symptoms based on the 5 domains diarrhoea, constipation, reflux, indigestion and abdominal pain. The symptoms are assessed with 15 items, ranging in scores 1 to 7 depending on their severity. A score of 1 represents "no problems" and score 7 represents "severe problems". The severity of symptoms may be defined as no problems (1 point), mild (1-2 points), moderate (2-4 points), and severe (4-7 points). The scores for each domain was calculated as the mean score of each corresponding item while the mean total GSRS score reflects the general severity of GI symptoms.
Measured: 1 day
Irritable bowel syndrome- symptom severity scale (IBS-SSS)
This scale evaluates five aspects of IBS during a 10-day period: abdominal pain, distension, stool frequency and consistency and interference with daily life. Each item is scored on a visual analogue scale from 0 to 100 and the sum is the total score. The scale is responsive to treatment and has good validity.
Measured: 1 day
Food Frequency Questionnaire (FFQ)
The dietary pattern will be assessed through a food frequency questionnaire that has been validated in a Swedish population. The questionnaire includes 174 foods and drinks and estimates the dietary pattern during one year. This is a common way to evaluate eating habits and in this way, evaluation of the microbiota composition in relation to dietary patterns is possible to assess.
Measured: 1 day
Hospital Anxiety and Depression Scale (HAD)
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of study participants.This questionnaire consists of 14 items subdivided in two subscales for the assessment of anxiety or depression. The total score is used as a measure of general psychological distress. The minimum score is 0 and the maximum score is 21. A score > 8 on respective subscales indicates a significant level of anxiety or depression.
Measured: 1 day
Perceived Stress Scale (PSS)
The perceived stress scale (PSS) consists of 10 items, including a number of direct questions about current levels of experienced stress. The respondent answers how often a certain emotion has been present during the past month. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4). The questions in this scale ask about the responders feelings and thoughts during the last month. In each case the questionnaire requires the respondent to indicate by circling how often they felt or thought a certain way.
Measured: 1 day
MDS Clinical Diagnostic Criteria for Parkinson's Disease
The MDS criteria use a two-step process of PD diagnosis. First, parkinsonism is defined (as bradykinesia in combination with either rest tremor, rigidity, or both). Once diagnosed, the criteria then define whether this parkinsonism is attributable to Parkinson's disease. Not scale-based.
Measured: 1 day
Hoehn and Yahr scale/stages (Modified scale)
The Hoehn and Yahr scale is one of the most commonly and most widely used scale to describe severity in stages 1-5 of Parkinson's disease worldwide. The modified form includes 0.5 increments.
Measured: 1 day
Clinical Impression of Severity Index for Parkinson's disease (CISI-PD)
The CISI-PD scale provides a clinical judgment on Parkinson's disease (PD) severity based on motor symptoms and complications, cognitive status, and disability. For each component, the score ranges from 0 (normal) to 6 (very severe). A brief definition is attached to each rank, and the sum of these four items yields a global index ranging from 0 to 24 points.
Measured: 1 day
Non-Motor Symptoms Questionnaire
An instrument to assess wide range of non-motor symptoms based on list of 30 items by answering with: Yes, Don't know, No. This instrument does not provide an overall score of disability and is not a graded or rating instrument. Instead, it is a screening tool designed to draw attention to the presence of non-motor symptoms and initiate further investigation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 May 2023
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- VHIR, Aston University, Region Örebro County
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, PhD/MD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573542
- Sponsor's protocol ID
- PARKIBS
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05573542
- Acronym / sponsor ID
- PARKIBS
- Conditions
- Parkinson Disease, Irritable Bowel Syndrome
- Keywords
- Alpha-synuclein, Intestinal permeability, Gut-brain axis, Mucosal ultrastructure, Brain function, Microbiota, Metabolomics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- VHIR, Aston University, Region Örebro County
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's | – | –Individuals with confirmed diagnosis of Parkinson's disease by neurologist. |
| Patients with irritable bowel syndrome | – | –Individuals with IBS according to ROME IV criterias |
| Healthy controls | – | –Healthy individuals lacking both IBS and Parkinson's disease, in addition to other criteras stated in the Eligibility section. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson patients will be recruited from the neurological department at Örebro University hospital by neurologist. Patients with IBS will be recruited from the gastroenterology deparments at Örebro University hospital by gastroenterologist. Healthy controls will be recruited via local advertisements or from previous study pools.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (55 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of alpha-synuclein
Time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project
Alpha-synuclein is the hallmark protein of Parkinson's disease and the presence of this protein will be detected with immunoflourescence in colonic tissues
18 secondary outcomes
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
Hospital Anxiety and Depression Scale (HAD)
Time frame: 1 day
Perceived Stress Scale (PSS)
Time frame: 1 day
MDS Clinical Diagnostic Criteria for Parkinson's Disease
Time frame: 1 day
Hoehn and Yahr scale/stages (Modified scale)
Time frame: 1 day
Clinical Impression of Severity Index for Parkinson's disease (CISI-PD)
Time frame: 1 day
Non-Motor Symptoms Questionnaire
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Brummer, PhD/MD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Irritable Bowel Syndrome, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of alpha-synuclein (time frame: Stored samples collected from a one day visit will be continously analysed during the 5 year project). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.