Parkinson DiseaseNCT06197698
A Proof-of-concept Study Evaluating the Microbiota-gut-brain Axis
A study testing F18-FDG, Tc-99m TRODAT-1 in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The concept of "Microbiota-gut-brain axis" has long been elucidated. However, only few microbiota-related radionuclide imaging studies have been published. The etiology of physiologic bowel FDG uptake is not fully understood. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- F18-FDG, Tc-99m TRODAT-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jan 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 80 Parkinson's disease patients over 20 years old (the Unified Parkinson's Disease Rating Scale and Hoehn-Yahr Grading Scale are required to provide clinical staging).
- 20 non-Parkinson's disease patients over 20 years old (control group).
- Those who are not currently using Metformin, can tolerate fasting for 8 hours, have not used antibiotics within 3 months, and have no obvious intestinal diseases.
- Subjects and their families agree to join the trial and agree to undergo fluorine-18 deoxyglucose positron imaging (100 subjects will be paid for by research funds) and phosphonium-99m dopamine transporter scan (20 non-Parkinson's patients will be paid for by research funds) syndrome patients) examination.
Who cannot join
- Unable to accept positron or single photon angiography such as checking for panic disorder and hemodynamic instability.
- The possible cancer risk caused by the radiation dose obtained from the experiment cannot be accepted.
- Pregnant women or women currently breastfeeding.
- There is a lack of recent unified Parkinson's disease rating scale and Hoehn-Yahr grading scale, making it impossible to know the clinical stage.
- Those who are currently using Metformin, cannot tolerate fasting for 8 hours, have used antibiotics within 3 months, and have obvious intestinal diseases.
- The subjects and their families do not agree to join the trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yunlin branch
Douliu
Yi-Hsien Chou, MD, +886-5-5323911 ext. 562600, iquanchou@gmail.com
About this study
The concept of "Microbiota-gut-brain axis" has long been elucidated. However, only few microbiota-related radionuclide imaging studies have been published. The etiology of physiologic bowel FDG uptake is not fully understood. Some previous studies suggested that bacteria play a role in accumulating FDG and the variability of intestinal FDG activity may rely on a specific type of bacteria in the lumen. It is unclear if FDG transfer from the blood to the bowel lumen through a transcellular or paracellular pathways. The GLUT transporters are known to export glucose from mucosal cells to the blood, but it is doubtful they can also transport in the opposite direction. Therefore, some research speculated the focal or intense FDG uptake might be caused by an increase in intestinal permeability and reflects intestinal barrier impairment.
Gut microbiota compositional changes may affect pathogenesis in patients with Parkinson's disease (PD). A previous hypothesis of PD pointed disease originates in the enteric nervous system and spreads via autonomic neurons to the brain, eventually causing PD. Besides, several studies support the clinical use of Tc-99m TRODAT-1 SPECT in assessing the neurodegenerative status of PD. To date, the correlation between physiologic bowel FDG uptake and dopamine transporter degeneration, as evaluated by either semiquantitative or visual analyses, has never been elucidated.
The objective of this study is to investigate the relationship between the pattern of intestinal FDG activity and Tc-99m TRODAT-1 SPECT images based on the theory of "Microbiota-gut-brain axis".
Read the detailed description
The key role of gut microbiota in keeping local and systemic homeostasis is termed the "Microbiota-gut-brain axis", which is a complex bidirectional communication system between the gastrointestinal tract and the brain. The hypothalamic-pituitary adrenal (HPA) axis takes part to this bidirectional communication by releasing corticotrophin-releasing factor (CRF), which facilitates the release of adenocorticotrophin hormone (ACTH) from the pituitary, which enters systemic circulation to lead to the release of cortisol from the adrenal glands. Many reports indicating that this hormonal cascade has a significant role in the adjustment of several functions like gastrointestinal transit, visceral sensation and permeability of the intestinal wall.
The etiology of intestinal FDG uptake without pathologic lesions is not fully understood. Tohihara et al. reported physiologic bowel FDG activity at the delayed phase was more than that at the early phase in dual-time images, and postulated FDG secretion was the major cause of physiologic uptake. Franquet et al. reported that physiologic bowel FDG uptake was inhibited by antibiotics, such as rifaximin. Some studies proposed that a specific type of bacteria in the lumen plays a role in gathering FDG, and it explain individual differences in physiologic bowel FDG activity. Previous studies debated about if FDG transfer from the blood to the bowel lumen through a transcellular or paracellular pathways. The GLUT transporters are known to export glucose from mucosal cells to the blood, but it is doubtful they can also transport in the opposite direction. If bowel FDG uptake is associated to intestinal permeability, FDG is likely to migrate through a paracellular pathway because intestinal permeability is adjusted by paracellular tight junction.
There is strong evidence that microbial strains may generate neuroactive molecules such as neurotransmitters, which may interfere with gut and brain functions. Furthermore, gut microbiota compositional changes may affect pathogenesis in patients with Parkinson's disease (PD). A previous hypothesis of PD pointed disease originates in the enteric nervous system and spreads via autonomic neurons to the brain, eventually causing PD. Besides, several studies support the clinical use of Tc-99m TRODAT-1 SPECT in assessing the neurodegenerative status of PD.
To date, no radionuclide imaging studies for correlation between physiologic bowel FDG uptake and dopamine transporter degeneration have been elucidated. The investigators hope to have insight into pathophysiology of PD by investigating the association between the pattern of intestinal FDG activity and Tc-99m TRODAT-1 SPECT images. In addition, research in this field opens the possibility to use neuroactive molecule-producing probiotics as new potential therapeutic tools for patients with PD.
- Conditions
- Parkinson Disease
- Being tested
- F18-FDG, Tc-99m TRODAT-1
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-FDG, Tc-99m TRODAT-1Diagnostic test
In this project, 18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients, and the nigrostriatal dopamine system is assessed by Tc-99m TRODAT-1 SPECT.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients | Other | We will investigate the correlation between 18F-FDC PET bowel uptake and dopamine transporter changes in patients with PD. Receives: Diagnostic Test: F18-FDG, Tc-99m TRODAT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameter (visual score 1-3)
Intestinal FDG uptake classified by visual analysis
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start3 Jan 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Hsien Chou, MD, Study director, NTUH Yunlin branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197698
- Sponsor's protocol ID
- 202112226MINC
- Status last verified
- Oct 2024
- First submitted
- 30 Nov 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study Evaluating the Microbiota-gut-brain Axis
- ClinicalTrials.gov ID
- NCT06197698
- Acronym / sponsor ID
- 202112226MINC
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Jan 2024 (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.
The concept of "Microbiota-gut-brain axis" has long been elucidated. However, only few microbiota-related radionuclide imaging studies have been published. The etiology of physiologic bowel FDG uptake is not fully understood. Some previous studies suggested that bacteria play a role in accumulating FDG and the variability of intestinal FDG activity may rely on a specific type of bacteria in the lumen. It is unclear if FDG transfer from the blood to the bowel lumen through a transcellular or paracellular pathways. The GLUT transporters are known to export glucose from mucosal cells to the blood, but it is doubtful they can also transport in the opposite direction. Therefore, some research speculated the focal or intense FDG uptake might be caused by an increase in intestinal permeability and reflects intestinal barrier impairment.
Gut microbiota compositional changes may affect pathogenesis in patients with Parkinson's disease (PD). A previous hypothesis of PD pointed disease originates in the enteric nervous system and spreads via autonomic neurons to the brain, eventually causing PD. Besides, several studies support the clinical use of Tc-99m TRODAT-1 SPECT in assessing the neurodegenerative status of PD. To date, the correlation between physiologic bowel FDG uptake and dopamine transporter degeneration, as evaluated by either semiquantitative or visual analyses, has never been elucidated.
The objective of this study is to investigate the relationship between the pattern of intestinal FDG activity and Tc-99m TRODAT-1 SPECT images based on the theory of "Microbiota-gut-brain axis".
Detailed description
The key role of gut microbiota in keeping local and systemic homeostasis is termed the "Microbiota-gut-brain axis", which is a complex bidirectional communication system between the gastrointestinal tract and the brain. The hypothalamic-pituitary adrenal (HPA) axis takes part to this bidirectional communication by releasing corticotrophin-releasing factor (CRF), which facilitates the release of adenocorticotrophin hormone (ACTH) from the pituitary, which enters systemic circulation to lead to the release of cortisol from the adrenal glands. Many reports indicating that this hormonal cascade has a significant role in the adjustment of several functions like gastrointestinal transit, visceral sensation and permeability of the intestinal wall.
The etiology of intestinal FDG uptake without pathologic lesions is not fully understood. Tohihara et al. reported physiologic bowel FDG activity at the delayed phase was more than that at the early phase in dual-time images, and postulated FDG secretion was the major cause of physiologic uptake. Franquet et al. reported that physiologic bowel FDG uptake was inhibited by antibiotics, such as rifaximin. Some studies proposed that a specific type of bacteria in the lumen plays a role in gathering FDG, and it explain individual differences in physiologic bowel FDG activity. Previous studies debated about if FDG transfer from the blood to the bowel lumen through a transcellular or paracellular pathways. The GLUT transporters are known to export glucose from mucosal cells to the blood, but it is doubtful they can also transport in the opposite direction. If bowel FDG uptake is associated to intestinal permeability, FDG is likely to migrate through a paracellular pathway because intestinal permeability is adjusted by paracellular tight junction.
There is strong evidence that microbial strains may generate neuroactive molecules such as neurotransmitters, which may interfere with gut and brain functions. Furthermore, gut microbiota compositional changes may affect pathogenesis in patients with Parkinson's disease (PD). A previous hypothesis of PD pointed disease originates in the enteric nervous system and spreads via autonomic neurons to the brain, eventually causing PD. Besides, several studies support the clinical use of Tc-99m TRODAT-1 SPECT in assessing the neurodegenerative status of PD.
To date, no radionuclide imaging studies for correlation between physiologic bowel FDG uptake and dopamine transporter degeneration have been elucidated. The investigators hope to have insight into pathophysiology of PD by investigating the association between the pattern of intestinal FDG activity and Tc-99m TRODAT-1 SPECT images. In addition, research in this field opens the possibility to use neuroactive molecule-producing probiotics as new potential therapeutic tools for patients with PD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients | Other | Diagnostic Test: F18-FDG, Tc-99m TRODAT-1We will investigate the correlation between 18F-FDC PET bowel uptake and dopamine transporter changes in patients with PD. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 80 Parkinson's disease patients over 20 years old (the Unified Parkinson's Disease Rating Scale and Hoehn-Yahr Grading Scale are required to provide clinical staging).
- 20 non-Parkinson's disease patients over 20 years old (control group).
- Those who are not currently using Metformin, can tolerate fasting for 8 hours, have not used antibiotics within 3 months, and have no obvious intestinal diseases.
- Subjects and their families agree to join the trial and agree to undergo fluorine-18 deoxyglucose positron imaging (100 subjects will be paid for by research funds) and phosphonium-99m dopamine transporter scan (20 non-Parkinson's patients will be paid for by research funds) syndrome patients) examination.
Key exclusion criteria (6 listed)
- Unable to accept positron or single photon angiography such as checking for panic disorder and hemodynamic instability.
- The possible cancer risk caused by the radiation dose obtained from the experiment cannot be accepted.
- Pregnant women or women currently breastfeeding.
- There is a lack of recent unified Parkinson's disease rating scale and Hoehn-Yahr grading scale, making it impossible to know the clinical stage.
- Those who are currently using Metformin, cannot tolerate fasting for 8 hours, have used antibiotics within 3 months, and have obvious intestinal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F18-FDG, Tc-99m TRODAT-1In this project, 18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients, and the nigrostriatal dopamine system is assessed by Tc-99m TRODAT-1 SPECT. | Diagnostic test | 18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients |
Primary outcome
Physiological parameter (visual score 1-3)
Time frame: through study completion, an average of 2 years
Intestinal FDG uptake classified by visual analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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. This study is not recruiting at the moment.
Yi-Hsien Chou, MD study director
NTUH Yunlin branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F18-FDG, Tc-99m TRODAT-1 in people with Parkinson Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Oct 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi-Hsien Chou, MD (+886-5-5323911 ext. 562600, iquanchou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter (visual score 1-3) (time frame: through study completion, an average of 2 years). 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 21 Oct 2024.