Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkins… (NCT07038226) | Clinical Trial Compass
CompletedNot Applicable
Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease
South Korea16 participantsStarted 2023-10-02
Plain-language summary
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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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:
A. On at least 1 out of 4 bowel movements, two or more of the following apply: i. Excessive straining.
ii. 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.
D. 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.
Exclusion Criteria:
* 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 ile…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in 39-Item Parkinson's Disease Questionnaire
Timeframe: Baseline up to Week 12
2
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0