NCT07038226Completed
Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease
Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomised Trial
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
The aim of this clinical trial is to assess the impact of fecal microbiota transplantation (FMT) delivered via oral capsules in patients with Parkinson's disease who suffer from refractory constipation. The primary questions this trial seeks to answer are: Does FMT delivered through oral capsules improve constipation? Does FMT delivered through oral capsules enhance the motor symptoms associated with Parkinson's disease? Is FMT delivered through oral capsules safe for individuals with Parkinson's disease? Researchers will compare the intervention group with a control group to determine the presence of a placebo effect. Participants in the study will: Take antibiotics as a pre-treatment regimen for 5 days, followed by oral capsules containing either fecal microbiota or a placebo for 14 days. Attend clinic visits at screening, visit 1 (baseline), visit 2 (4 weeks), and visit 3 (12 weeks). Collect fecal samples and maintain a 2-week diary of their bowel habits before visits 1, 2, and 3.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 4 Jun 2025
- Start date
- 2 Oct 2023
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Kyung Hee University Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07038226
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 2 Oct 2023 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.