A Proof-of-concept Study Evaluating the Microbiota-gut-brain Axis

Recruiting now · Not applicable

Conditions studied: Parkinson Disease

In brief

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".

Key facts

Study ID: NCT06197698
Run by: National Taiwan University Hospital
People needed: 100
Starts: 2023-01-03
Expected to finish: 2025-02-28
Last updated by the study team: 2024-10-21

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

National Taiwan University Hospital Yunlin branch — Douliu, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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