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

NCT06197698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-21

No results posted yet for this study

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".

Conditions

  • Parkinson Disease

Interventions

DIAGNOSTIC_TEST

F18-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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Yi-Hsien Chou, MD · NTUH Yunlin branch

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-03
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197698 on ClinicalTrials.gov