RecruitingNot ApplicableNCT06197698

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


Sponsor

National Taiwan University Hospital

Enrollment

100 participants

Start Date

Jan 3, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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".


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study investigates the connection between gut bacteria (microbiome) and brain function in people with Parkinson's disease. It explores whether changes in the gut microbiome are linked to thinking and movement problems in Parkinson's patients, and whether a drug called metformin can influence this connection. **You may be eligible if...** - You are over 20 years old - You have been diagnosed with Parkinson's disease (and have been clinically staged) - You are not currently taking metformin - You can fast for 8 hours before a sample is taken - You have not taken antibiotics in the past 3 months - You do not have significant bowel or intestinal disease - A healthy control group (without Parkinson's) is also being enrolled **You may NOT be eligible if...** - You currently take metformin - You have used antibiotics in the last 3 months - You have significant intestinal disease - You are unable to fast for 8 hours Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTF18-FDG, Tc-99m TRODAT-1

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.


Locations(1)

National Taiwan University Hospital Yunlin branch

Douliu, Taiwan

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NCT06197698


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