Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease

Korábbi kezelés

• Individuals receiving parenteral nutrition or enteral feeding.
• Individuals who have taken antibiotics within 3 months prior to screening.
• Individuals who have participated in other drug clinical trials within 3 months prior to screening.

Más betegség

• Individuals with cognitive impairment scoring less than 20 on the Korean version of the Mini-Mental State Examination (K-MMSE).
• Individuals who have contraindications for fecal microbiota transplantation (acute infections, immunocompromised status, or a history of food allergies).
• Individuals with a history of major gastrointestinal surgeries, such as resection.
• Individuals with suspected or confirmed active gastrointestinal bleeding.
• Individuals with gastrointestinal diseases requiring treatment or medical consultation.
• Individuals with other severe diseases that may impair quality of life or the ability to perform daily activities.

Egyéb

• Individuals with ileus or colonic pseudo-obstruction.
• Individuals with suspected or confirmed gastrointestinal obstruction or gastric outlet obstruction.
• Individuals experiencing dysphagia symptoms (difficulty swallowing, choking during meals, etc.).
• Pregnant individuals.
• Individuals with contraindications to the use of antibiotics (Ciprofloxacin, Metronidazole) as referenced in the text.
• Any other case where the researcher deems participation in the clinical trial to be inappropriate for the subject.

• Aged between 40 and 80 years.
• Voluntarily signed the informed consent form for participation in this study.
• Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria.
• Either do not have or have controlled Parkinson's disease motor complications, allowing for stable use of anti-Parkinson's medication during the study period (12 weeks).
• Meet the definition of refractory constipation as follows:
• On at least 1 out of 4 bowel movements, two or more of the following apply: i. Excessive straining.
• Lumpy/hard stools (Bristol Stool Form Scale 1-2). iii. Sensation of incomplete evacuation after defecation. iv. Sensation of anorectal obstruction or blockage. v. Manual maneuvers to facilitate defecation. vi. Fewer than three spontaneous bowel movements per week. B. Rarely experience loose stools without the use of laxatives. C. Symptoms began at least 6 months prior to diagnosis and have persisted for the past 3 months.
• Constipation shows no improvement despite the use of various types of laxatives (bulk-forming, osmotic, saline, stimulant, or others) individually or in combination for at least 4 weeks.