Unique ID issued by UMIN | UMIN000040889 |
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Receipt number | R000046691 |
Scientific Title | Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease |
Date of disclosure of the study information | 2020/06/24 |
Last modified on | 2023/10/08 22:31:39 |
Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease
Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease
Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease
Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease
Japan |
Parkinson's disease
Gastroenterology | Neurology |
Others
YES
To determine the effect of Levodopa-carbidopa continuous infusion gel therapy (LCIG) on leaky gut syndrome (LGS), small intestinal bacterial overgrowth(SIBO), and esophageal function of patients with Parkinson's disease
Efficacy
Exploratory
Pragmatic
Phase IV
Change in the following findings:
1. Lactulose/mannitol test
2. Hydrogen and methane breath test
3. Barium meal roentgenogram and high resolution manometry of the esophagus
Change in the following findings:
1. EGD and colonoscopy including immunohistochemistry with alpha-sinuclein antibody of endoscopic biopsy specimens
2. Questionaire with GSRS, SF-36, IBS-Q
3. Fecal microbiota analysis
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Levodopa-carbidopa continuous infusion gel (LCIG) therapy
20 | years-old | <= |
Not applicable |
Male and Female
Patients who were diagnosed as Parkinson's disease according to MDS criteria
1. Patients on immunosuppresant
2. Patients who underwent small bowel resection
3. Patients with severe hepatic and renal insufficiency
4. Patients with anemia
5. Pregnant or lactating women
6. Patients with diabetes mellitus
7. Patients whom attending physicians consider inappropriate for enrollment
200
1st name | Naoki |
Middle name | |
Last name | Ohmiya |
Fujita Health University School of Medicine
Department of Gastroenterology
470-1192
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
0562-93-9240
nohmiya@fujita-hu.ac.jp
1st name | Ikue |
Middle name | |
Last name | Tanigawa |
Fujita Health University School of Medicine
IRB
470-1192
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
0562-93-2860
research@fujita-hu.ac.jp
Fujita Health University School of Medicine
Department of Gastroenterology
self funding
Self funding
Fujita Health University School of Medicine, IRB
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
0562-93-2860
research@fujita-hu.ac.jp
NO
藤田医科大学病院(愛知県)
2020 | Year | 06 | Month | 24 | Day |
Unpublished
We will enroll patients from now.
2020 | Year | 06 | Month | 24 | Day |
Terminated
2020 | Year | 04 | Month | 12 | Day |
2020 | Year | 06 | Month | 24 | Day |
2020 | Year | 06 | Month | 24 | Day |
2025 | Year | 03 | Month | 31 | Day |
2025 | Year | 05 | Month | 31 | Day |
2025 | Year | 06 | Month | 30 | Day |
2025 | Year | 08 | Month | 31 | Day |
2020 | Year | 06 | Month | 24 | Day |
2023 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046691
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