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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 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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040889
Enrollment
200
Registered
2020-06-24
Start date
2020-06-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

Levodopa-carbidopa continuous infusion gel (LCIG) therapy

Sponsors

Fujita Health University School of Medicine Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who were diagnosed as Parkinson's disease according to MDS criteria

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
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—

Countries

Japan

Contacts

Public ContactIkue Tanigawa

Fujita Health University School of Medicine IRB

research@fujita-hu.ac.jp0562-93-2860

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026