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

NCT06197698 | Recruiting

• 1 other identifier: 202112226MINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Physiological parameter (visual score 1-3)

  Intestinal FDG uptake classified by visual analysis

  through study completion, an average of 2 years

Study Arms (1)

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.

Diagnostic Test: F18-FDG, Tc-99m TRODAT-1

Interventions

F18-FDG, Tc-99m TRODAT-1 DIAGNOSTIC_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.

18F-FDG PET is used as an imaging marker of gut microbiota composition evaluation in PD patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Yunlin branch

Douliu, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yi-Hsien Chou, MD

  NTUH Yunlin branch

  STUDY DIRECTOR

Central Study Contacts

Yi-Hsien Chou, MD

CONTACT

+886-5-5323911; iquanchou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: January 9, 2024
• Study Start: January 3, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

TW (1)