- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05573542
Early Signs of Parkinsons Disease in IBS
Early Signs of Parkinson's Disease Pathology in the Colon of Patients With Irritable Bowel Syndrome
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: John-Peter Ganda Mall, PhD
- Phone Number: +46 707751383
- Email: john-peter.Ganda-Mall@oru.se
Study Locations
-
-
-
Örebro, Sweden, 70362
- Campus USÖ, Örebro University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Patients with Parkinson's disease
Inclusion Criteria:
- Confirmed diagnosis by neurologist
- Males or females aged 45-85 years
- Signed informed consent
Exclusion Criteria:
- 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.
- 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
Inclusion Criteria:
- Fulfilling ROME IV criteria upon recruitment
- Minimum 5 year of IBS symptoms
- Males or females aged 18-85 years
- Signed informed consent
Exclusion criteria:
- 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
Exclusion criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Stored samples collected from a one day visit will be continously analysed during the 5 year project
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intestinal permeability
Time Frame: 1 day
|
Colonic permeability measured by biopsies mounted in Ussing chambers
|
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
|
Morphologic quantification of cell size and granule density using Electron microscopy
|
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
|
Quantitative measurement of distance between cells to interpolate cell-to-cell interaction using Electron microscopy
|
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
|
Analysis of faecal microbiota composition and function (metagenomics)
|
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
|
Metabolomic analysis of inflammatory markers, sex hormones and enviromental pollutants in blood and faeces
|
Stored samples collected from a one day visit will be continously analysed during the 5 year project
|
Brain function
Time Frame: 1day
|
Structural and functional alterations in the brain and brainstem using functional magnetic resonance imaging
|
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
|
Measure the potential of alpha-synuclein to form aggregates in colonic biopsies
|
Stored samples collected from a one day visit will be continously analysed during the 5 year project
|
Platelet aggregation
Time Frame: 1 day
|
Platelets will be isolated from blood samples and run on an aggregometer to elcuidate platelet aggregation potential
|
1 day
|
Immunophenotyping
Time Frame: 1 day
|
Lamina propria lymphocytes will be characterised for their immune-neurophenotype using flow cytometry
|
1 day
|
Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome version (GSRS-IBS)
Time Frame: 1 day
|
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.
|
1 day
|
Irritable bowel syndrome- symptom severity scale (IBS-SSS)
Time Frame: 1 day
|
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.
|
1 day
|
Food Frequency Questionnaire (FFQ)
Time Frame: 1 day
|
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.
|
1 day
|
Hospital Anxiety and Depression Scale (HAD)
Time Frame: 1 day
|
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.
|
1 day
|
Perceived Stress Scale (PSS)
Time Frame: 1 day
|
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.
|
1 day
|
MDS Clinical Diagnostic Criteria for Parkinson's Disease
Time Frame: 1 day
|
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.
|
1 day
|
Hoehn and Yahr scale/stages (Modified scale)
Time Frame: 1 day
|
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.
|
1 day
|
Clinical Impression of Severity Index for Parkinson's disease (CISI-PD)
Time Frame: 1 day
|
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.
|
1 day
|
Non-Motor Symptoms Questionnaire
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert J Brummer, PhD/MD, Örebro University, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Gastrointestinal Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Parkinson Disease
- Irritable Bowel Syndrome
Other Study ID Numbers
- PARKIBS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain