Parkinson DiseaseFORT-PDNCT07038226
Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease
A study testing Oral capsule-delivered FMT in people with Parkinson Disease and Constipation, run by Kyung Hee University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Constipation
- What is being tested?
- Oral capsule-delivered FMT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2023to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ileus or colonic pseudo-obstruction.
- Individuals with a history of major gastrointestinal surgeries, such as resection.
- Individuals with suspected or confirmed gastrointestinal obstruction or gastric outlet obstruction.
- Individuals with suspected or confirmed active gastrointestinal bleeding.
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- Individuals with gastrointestinal diseases requiring treatment or medical consultation.
- Individuals receiving parenteral nutrition or enteral feeding.
- Individuals experiencing dysphagia symptoms (difficulty swallowing, choking during meals, etc.).
- 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.
- Pregnant individuals.
- Individuals with other severe diseases that may impair quality of life or the ability to perform daily activities.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomised Trial
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.
Read more
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.
- Conditions
- Parkinson Disease, Constipation
- Being tested
- Placebo, Oral capsule-delivered FMT
- Keywords
- fecal transplantation, oral capsule
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
a visually identical capsule containing skim milk powder
Oral capsule-delivered FMTBiological
Oral capsules of lysophilized fecal microbiota
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive a visually identical capsule containing skim milk powder. Receives: Biological: Placebo |
| Oral capsule-delivered FMT | Experimental | Participants will receive oral capsules of lysophilized fecal microbiota. Receives: Biological: Oral capsule-delivered FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 39-Item Parkinson's Disease Questionnaire
The minimum score is 0 and the maximum score is 100, with higher scores indicating worse quality of life.
Measured: Baseline up to Week 12
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Any adverse effects derived from the intervention
Measured: up to 12 weeks
Secondary outcomes (4)
Change from baseline in Wexner Constipation Score
The minimum score is 0 and a maximum score is 30, with higher scores indicating more severe constipation.
Measured: Baseline up to Week 12
Change from baseline in Bristol stool scale
The Bristol Stool Chart classifies stool types on a scale of 1 to 7, with 1 being the hardest and 7 being the most liquid.
Measured: Baseline up to Week 12
Change from baseline in Geriatric Depression Scale-15 (short version)
The total score range is 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: Baseline up to Week 12
Change from baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with Hoehn and Yahr Stage (HYS)
The MDS-UPDRS has a total possible score of 260, with higher scores indicating greater disability. The HYS ranges from 0 to 5, or a clinical staging system that describes the progression of motor symptoms.
Measured: Baseline up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start2 Oct 2023
- Primary completion30 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Responsible party
- Principal investigator, Tae-Beom Ahn, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038226
- Sponsor's protocol ID
- KHUH 2023-03-002-008
- Other IDs
- 2022
- Acronym
- FORT-PD
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomised Trial
- ClinicalTrials.gov ID
- NCT07038226
- Acronym / sponsor ID
- FORT-PD / KHUH 2023-03-002-008
- Conditions
- Parkinson Disease, Constipation
- Keywords
- fecal transplantation, oral capsule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyung Hee University HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Hospital
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive a visually identical capsule containing skim milk powder. |
| Oral capsule-delivered FMT | Experimental | Biological: Oral capsule-delivered FMTParticipants will receive oral capsules of lysophilized fecal microbiota. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (15 listed)
- 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 ileus or colonic pseudo-obstruction.
- Individuals with a history of major gastrointestinal surgeries, such as resection.
- Individuals with suspected or confirmed gastrointestinal obstruction or gastric outlet obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboa visually identical capsule containing skim milk powder | Biological | Placebo |
| Oral capsule-delivered FMTOral capsules of lysophilized fecal microbiota | Biological | Oral capsule-delivered FMT |
Primary outcome
Change from baseline in 39-Item Parkinson's Disease Questionnaire
Time frame: Baseline up to Week 12
The minimum score is 0 and the maximum score is 100, with higher scores indicating worse quality of life.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: up to 12 weeks
Any adverse effects derived from the intervention
4 secondary outcomes
Change from baseline in Wexner Constipation Score
Time frame: Baseline up to Week 12
Change from baseline in Bristol stool scale
Time frame: Baseline up to Week 12
Change from baseline in Geriatric Depression Scale-15 (short version)
Time frame: Baseline up to Week 12
Change from baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with Hoehn and Yahr Stage (HYS)
Time frame: Baseline up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral capsule-delivered FMT in people with Parkinson Disease and Constipation, run by Kyung Hee University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 39-Item Parkinson's Disease Questionnaire (time frame: Baseline up to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.