Parkinson's DiseaseFMTNCT07597421
Fecal Microbiota Transplantation in Parkinson's Disease.
A study testing Fecal microbiota transplantation and Not received Fecal microbiota transplantation in people with Parkinson's Disease, run by Chang Gung Memorial Hospital.
Trial summary
Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI). Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Fecal microbiota transplantation and Not received Fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 7 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic PD according to UK brain bank criteria.
- PD disease duration ≧5 years to avoid the possible misdiagnosis of atypical parkinsonism.
- Hoehn-Yahr stage 1-4
- Using levodopa in a currently fixed dose.
- Presence of motor complications (motor fluctuation or dyskinesia).
- Written informed consent.
- Age above 18.
Who cannot join
- Hoehn-Yahr stage 5. (wheelchair ridden or bedridden due to PD)
- Dementia (MMSE<24), history of encephalitis, or brain organic lesions, including congenital or acquired structural abnormalities (which were detected through brain computed tomography scan or Magnetic Resonance Imaging) may affect neurological function, leading to various neurological deficits and mpairing the cognitive function.
- Current use of probiotics or in the past 3 months.
- For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
- Current need of antibiotics or use in the previous 3 months.
- End stage renal disease caused uremic encephalopathy or liver cirrhosis caused hepatic encephalopathy
- Immunocompromised state.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fecal Microbiota Transplantation for the Treatment of Patients With Parkinson's Disease.
Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI). Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis. This study is a pilot study to apply FMT on patients with Parkinson's disease (PD). The effect of FMT on motor and non-motor symptoms in PD will be also evaluated.
Read the detailed description
- Screening and Enrollment Participants will be recruited from movement disorders clinics at Chang Gung Memorial Hospital (CGMH). Written informed consent will be obtained prior to study participation. Control group participants will undergo the same evaluation protocol as the treatment group, except for fecal microbiota transplantation (FMT).
- Clinical Assessments Before the baseline visit, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed. Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT. Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months.
- Donor Screening and Specimen Processing Healthy donors will undergo comprehensive screening, including medical history, risk assessment, and laboratory testing, in accordance with national FMT consensus guidelines. Eligible donors will provide stool samples under standardized conditions. Samples will be processed at the CGMH microbiota center following established protocols, including preparation for microbiome and metabolite analyses (e.g., short-chain fatty acids) using validated laboratory methods such as gas chromatography-mass spectrometry (GC-MS). Blood samples from participants will also be collected and stored for analysis.
- Clinical Outcome Measures Assessments will include: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS, on/off medication) Hoehn and Yahr stage Levodopa equivalent daily dose (LEDD) Motor complications (3-day diary) Montreal Cognitive Assessment (MoCA) Patient-reported outcomes: Wearing-Off Questionnaire (WOQ-9) Parkinson's Disease Questionnaire (PDQ-39) SENS-PD (non-dopaminergic symptoms) Parkinson's Disease Constipation Questionnaire (PDCQ)
- FMT Procedure Participants in the treatment group will receive oral vancomycin (125 mg every 6 hours for 3 days) and follow a low-fiber diet prior to FMT. After bowel preparation and a 24-hour washout period, processed donor microbiota will be delivered to the terminal ileum or cecum via ileocolonoscopy. Participants will remain in the right lateral position for at least 30 minutes post-procedure.
- Specimen Storage All collected specimens will be stored at -80°C at the microbiota center until study completion. Residual samples will be transferred to the institutional biobank or destroyed according to participant consent.
- Transportation Microbiota preparations will be transported under controlled temperature conditions. For intra-hospital use, samples will be delivered immediately with cold-chain protection. For inter-hospital transport, samples will be frozen at -80°C, shipped on dry ice, and used on the day of arrival or stored for up to 180 days.
- Quality Control and Follow-up All procedures, including donor selection, sample processing, and patient care, will follow national FMT consensus guidelines. Participants will be monitored at scheduled follow-ups (1 week, 3 months, and 6 months), with additional assessments arranged as needed to ensure safety and data completeness.
- Conditions
- Parkinson's Disease
- Being tested
- Fecal microbiota transplantation, Not received Fecal microbiota transplantation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationProcedure or surgery
All subjects in the treatment group will receive FMT once. Recipients must adhere to a low-fiber diet for three days, and pre-treatment antibiotics with Vancomycin 125 mg, administered as 2 capsules every 6 hours for 3 days. After a 24-hour washout period, they underwent colon preparation followed by FMT. During the procedure, processed 250cc microbiota fluid from healthy donors, provided by the Chang Gung fecal bank, was administered into the terminal ileum or cecum via ileocolonoscopy. To ensure safety and traceability, only a single-donor microbiota is used. After FMT, patients were instructed to lie on their right side for at least 30 minutes.
Not received Fecal microbiota transplantationProcedure or surgery
All subjects in the Control group will not receive FMT.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In the experimental group, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed.
Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT.
Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months. Receives: Procedure: Fecal microbiota transplantation |
| Control Group | Active comparator | In the control group, all the assessments will be conducted at the baseline, 3 months, and 6 months. Stool samples will be collected at baseline, 3 months, and 6 months. Receives: Procedure: Not received Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The improvement of the motor section scores of MDS-UPDRS in an off- medication state, from baseline to 6 months post-FMT for the treatment group compared to the control group.
Measured: 6 months
Secondary outcomes (1)
Secondary endpoints
The change of levodopa-equivalent daily dose (LEDD) and non-motor symptoms of patients with PD after FMT.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion7 Apr 2029 (estimated)
- Study completion7 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiung-Chu Chen, PhD., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597421
- Sponsor's protocol ID
- 202401790A0
- Acronym
- FMT
- Status last verified
- Apr 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Savica R, Carlin JM, Grossardt BR, Bower JH, Ahlskog JE, Maraganore DM, Bharucha AE, Rocca WA. Medical records documentation of constipation preceding Parkinson disease: A case-control study. Neurology. 2009 Nov 24;73(21):1752-8. doi: 10.1212/WNL.0b013e3181c34af5.
PubMed 19933976Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.
PubMed 9278044Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.
PubMed 24240814Shannon KM, Keshavarzian A, Dodiya HB, Jakate S, Kordower JH. Is alpha-synuclein in the colon a biomarker for premotor Parkinson's disease? Evidence from 3 cases. Mov Disord. 2012 May;27(6):716-9. doi: 10.1002/mds.25020. Epub 2012 May 1.
PubMed 22550057Sprenger FS, Stefanova N, Gelpi E, Seppi K, Navarro-Otano J, Offner F, Vilas D, Valldeoriola F, Pont-Sunyer C, Aldecoa I, Gaig C, Gines A, Cuatrecasas M, Hogl B, Frauscher B, Iranzo A, Wenning GK, Vogel W, Tolosa E, Poewe W. Enteric nervous system alpha-synuclein immunoreactivity in idiopathic REM sleep behavior disorder. Neurology. 2015 Nov 17;85(20):1761-8. doi: 10.1212/WNL.0000000000002126. Epub 2015 Oct 16.
PubMed 26475692Stokholm MG, Danielsen EH, Hamilton-Dutoit SJ, Borghammer P. Pathological alpha-synuclein in gastrointestinal tissues from prodromal Parkinson disease patients. Ann Neurol. 2016 Jun;79(6):940-9. doi: 10.1002/ana.24648. Epub 2016 Apr 9.
PubMed 27015771Liu B, Fang F, Pedersen NL, Tillander A, Ludvigsson JF, Ekbom A, Svenningsson P, Chen H, Wirdefeldt K. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 May 23;88(21):1996-2002. doi: 10.1212/WNL.0000000000003961. Epub 2017 Apr 26.
PubMed 28446653Svensson E, Horvath-Puho E, Thomsen RW, Djurhuus JC, Pedersen L, Borghammer P, Sorensen HT. Vagotomy and subsequent risk of Parkinson's disease. Ann Neurol. 2015 Oct;78(4):522-9. doi: 10.1002/ana.24448. Epub 2015 Jul 17.
PubMed 26031848Kim S, Kwon SH, Kam TI, Panicker N, Karuppagounder SS, Lee S, Lee JH, Kim WR, Kook M, Foss CA, Shen C, Lee H, Kulkarni S, Pasricha PJ, Lee G, Pomper MG, Dawson VL, Dawson TM, Ko HS. Transneuronal Propagation of Pathologic alpha-Synuclein from the Gut to the Brain Models Parkinson's Disease. Neuron. 2019 Aug 21;103(4):627-641.e7. doi: 10.1016/j.neuron.2019.05.035. Epub 2019 Jun 26.
PubMed 31255487Cryan JF, O'Riordan KJ, Sandhu K, Peterson V, Dinan TG. The gut microbiome in neurological disorders. Lancet Neurol. 2020 Feb;19(2):179-194. doi: 10.1016/S1474-4422(19)30356-4. Epub 2019 Nov 18.
PubMed 31753762Aho VTE, Houser MC, Pereira PAB, Chang J, Rudi K, Paulin L, Hertzberg V, Auvinen P, Tansey MG, Scheperjans F. Relationships of gut microbiota, short-chain fatty acids, inflammation, and the gut barrier in Parkinson's disease. Mol Neurodegener. 2021 Feb 8;16(1):6. doi: 10.1186/s13024-021-00427-6.
PubMed 33557896Forsyth CB, Shannon KM, Kordower JH, Voigt RM, Shaikh M, Jaglin JA, Estes JD, Dodiya HB, Keshavarzian A. Increased intestinal permeability correlates with sigmoid mucosa alpha-synuclein staining and endotoxin exposure markers in early Parkinson's disease. PLoS One. 2011;6(12):e28032. doi: 10.1371/journal.pone.0028032. Epub 2011 Dec 1.
PubMed 22145021Mulak A, Koszewicz M, Panek-Jeziorna M, Koziorowska-Gawron E, Budrewicz S. Fecal Calprotectin as a Marker of the Gut Immune System Activation Is Elevated in Parkinson's Disease. Front Neurosci. 2019 Sep 27;13:992. doi: 10.3389/fnins.2019.00992. eCollection 2019.
PubMed 31611762Perez-Pardo P, Dodiya HB, Engen PA, Forsyth CB, Huschens AM, Shaikh M, Voigt RM, Naqib A, Green SJ, Kordower JH, Shannon KM, Garssen J, Kraneveld AD, Keshavarzian A. Role of TLR4 in the gut-brain axis in Parkinson's disease: a translational study from men to mice. Gut. 2019 May;68(5):829-843. doi: 10.1136/gutjnl-2018-316844. Epub 2018 Dec 15.
PubMed 30554160Schwiertz A, Spiegel J, Dillmann U, Grundmann D, Burmann J, Fassbender K, Schafer KH, Unger MM. Fecal markers of intestinal inflammation and intestinal permeability are elevated in Parkinson's disease. Parkinsonism Relat Disord. 2018 May;50:104-107. doi: 10.1016/j.parkreldis.2018.02.022. Epub 2018 Feb 12.
PubMed 29454662
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for the Treatment of Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07597421
- Acronym / sponsor ID
- FMT / 202401790A0
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 7 Apr 2029 (estimated)
- Study completion
- 7 Apr 2029 (estimated)
- First posted
- 19 May 2026 (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.
Fecal microbiota transplantation (FMT) is an effective and safe treatment for Clostridioides difficile infection (CDI). Though CDI is the only indication for FMT, more and more preliminary data on FMT in neurological disorders are reported due to gut-brain axis. This study is a pilot study to apply FMT on patients with Parkinson's disease (PD). The effect of FMT on motor and non-motor symptoms in PD will be also evaluated.
Detailed description
- Screening and Enrollment Participants will be recruited from movement disorders clinics at Chang Gung Memorial Hospital (CGMH). Written informed consent will be obtained prior to study participation. Control group participants will undergo the same evaluation protocol as the treatment group, except for fecal microbiota transplantation (FMT).
- Clinical Assessments Before the baseline visit, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed. Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT. Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months.
- Donor Screening and Specimen Processing Healthy donors will undergo comprehensive screening, including medical history, risk assessment, and laboratory testing, in accordance with national FMT consensus guidelines. Eligible donors will provide stool samples under standardized conditions. Samples will be processed at the CGMH microbiota center following established protocols, including preparation for microbiome and metabolite analyses (e.g., short-chain fatty acids) using validated laboratory methods such as gas chromatography-mass spectrometry (GC-MS). Blood samples from participants will also be collected and stored for analysis.
- Clinical Outcome Measures Assessments will include: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS, on/off medication) Hoehn and Yahr stage Levodopa equivalent daily dose (LEDD) Motor complications (3-day diary) Montreal Cognitive Assessment (MoCA) Patient-reported outcomes: Wearing-Off Questionnaire (WOQ-9) Parkinson's Disease Questionnaire (PDQ-39) SENS-PD (non-dopaminergic symptoms) Parkinson's Disease Constipation Questionnaire (PDCQ)
- FMT Procedure Participants in the treatment group will receive oral vancomycin (125 mg every 6 hours for 3 days) and follow a low-fiber diet prior to FMT. After bowel preparation and a 24-hour washout period, processed donor microbiota will be delivered to the terminal ileum or cecum via ileocolonoscopy. Participants will remain in the right lateral position for at least 30 minutes post-procedure.
- Specimen Storage All collected specimens will be stored at -80°C at the microbiota center until study completion. Residual samples will be transferred to the institutional biobank or destroyed according to participant consent.
- Transportation Microbiota preparations will be transported under controlled temperature conditions. For intra-hospital use, samples will be delivered immediately with cold-chain protection. For inter-hospital transport, samples will be frozen at -80°C, shipped on dry ice, and used on the day of arrival or stored for up to 180 days.
- Quality Control and Follow-up All procedures, including donor selection, sample processing, and patient care, will follow national FMT consensus guidelines. Participants will be monitored at scheduled follow-ups (1 week, 3 months, and 6 months), with additional assessments arranged as needed to ensure safety and data completeness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Fecal microbiota transplantationIn the experimental group, participants will complete a 3-day diary documenting motor symptoms, non-motor symptoms, and medication timing. At each visit, neurological examinations and standardized Parkinson's disease (PD) assessments will be performed. Adverse events (AEs) and serious adverse events (SAEs) will be recorded throughout the study, regardless of causality, and categorized by their relationship to FMT. Follow-up assessments will be conducted at 1 week, 3 months, and 6 months after FMT. Stool samples will be collected at baseline, 3 months, and 6 months. |
| Control Group | Active comparator | Procedure: Not received Fecal microbiota transplantationIn the control group, all the assessments will be conducted at the baseline, 3 months, and 6 months. Stool samples will be collected at baseline, 3 months, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of idiopathic PD according to UK brain bank criteria.
- PD disease duration ≧5 years to avoid the possible misdiagnosis of atypical parkinsonism.
- Hoehn-Yahr stage 1-4
- Using levodopa in a currently fixed dose.
- Presence of motor complications (motor fluctuation or dyskinesia).
Key exclusion criteria (7 listed)
- Hoehn-Yahr stage 5. (wheelchair ridden or bedridden due to PD)
- Dementia (MMSE<24), history of encephalitis, or brain organic lesions, including congenital or acquired structural abnormalities (which were detected through brain computed tomography scan or Magnetic Resonance Imaging) may affect neurological function, leading to various neurological deficits and mpairing the cognitive function.
- Current use of probiotics or in the past 3 months.
- For women with childbearing potential. (Female participants are suggested to prevent pregnancy during this trial and undergo a pregnancy test before enrollment.)
- Current need of antibiotics or use in the previous 3 months.
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 |
|---|---|---|
| Fecal microbiota transplantationAll subjects in the treatment group will receive FMT once. Recipients must adhere to a low-fiber diet for three days, and pre-treatment antibiotics with Vancomycin 125 mg, administered as 2 capsules every 6 hours for 3 days. After a 24-hour washout period, they underwent colon preparation followed by FMT. During the procedure, processed 250cc microbiota fluid from healthy donors, provided by the Chang Gung fecal bank, was administered into the terminal ileum or cecum via ileocolonoscopy. To ensure safety and traceability, only a single-donor microbiota is used. After FMT, patients were instructed to lie on their right side for at least 30 minutes. | Procedure or surgery | Experimental Group |
| Not received Fecal microbiota transplantationAll subjects in the Control group will not receive FMT. | Procedure or surgery | Control Group |
Primary outcome
Primary endpoint
Time frame: 6 months
The improvement of the motor section scores of MDS-UPDRS in an off- medication state, from baseline to 6 months post-FMT for the treatment group compared to the control group.
1 secondary outcome
Secondary endpoints
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 19933976Savica R, Carlin JM, Grossardt BR, Bower JH, Ahlskog JE, Maraganore DM, Bharucha AE, Rocca WA. Medical records documentation of constipation preceding Parkinson disease: A case-control study. Neurology. 2009 Nov 24;73(21):1752-8. doi: 10.1212/WNL.0b013e3181c34af5.
- Background: PubMed 9278044Spillantini MG, Schmidt ML, Lee VM, Trojanowski JQ, Jakes R, Goedert M. Alpha-synuclein in Lewy bodies. Nature. 1997 Aug 28;388(6645):839-40. doi: 10.1038/42166. No abstract available.
- Background: PubMed 24240814Hilton D, Stephens M, Kirk L, Edwards P, Potter R, Zajicek J, Broughton E, Hagan H, Carroll C. Accumulation of alpha-synuclein in the bowel of patients in the pre-clinical phase of Parkinson's disease. Acta Neuropathol. 2014 Feb;127(2):235-41. doi: 10.1007/s00401-013-1214-6. Epub 2013 Nov 17.
- Background: PubMed 22550057Shannon KM, Keshavarzian A, Dodiya HB, Jakate S, Kordower JH. Is alpha-synuclein in the colon a biomarker for premotor Parkinson's disease? Evidence from 3 cases. Mov Disord. 2012 May;27(6):716-9. doi: 10.1002/mds.25020. Epub 2012 May 1.
- Background: PubMed 26475692Sprenger FS, Stefanova N, Gelpi E, Seppi K, Navarro-Otano J, Offner F, Vilas D, Valldeoriola F, Pont-Sunyer C, Aldecoa I, Gaig C, Gines A, Cuatrecasas M, Hogl B, Frauscher B, Iranzo A, Wenning GK, Vogel W, Tolosa E, Poewe W. Enteric nervous system alpha-synuclein immunoreactivity in idiopathic REM sleep behavior disorder. Neurology. 2015 Nov 17;85(20):1761-8. doi: 10.1212/WNL.0000000000002126. Epub 2015 Oct 16.
- Background: PubMed 27015771Stokholm MG, Danielsen EH, Hamilton-Dutoit SJ, Borghammer P. Pathological alpha-synuclein in gastrointestinal tissues from prodromal Parkinson disease patients. Ann Neurol. 2016 Jun;79(6):940-9. doi: 10.1002/ana.24648. Epub 2016 Apr 9.
- Background: PubMed 28446653Liu B, Fang F, Pedersen NL, Tillander A, Ludvigsson JF, Ekbom A, Svenningsson P, Chen H, Wirdefeldt K. Vagotomy and Parkinson disease: A Swedish register-based matched-cohort study. Neurology. 2017 May 23;88(21):1996-2002. doi: 10.1212/WNL.0000000000003961. Epub 2017 Apr 26.
- Background: PubMed 26031848Svensson E, Horvath-Puho E, Thomsen RW, Djurhuus JC, Pedersen L, Borghammer P, Sorensen HT. Vagotomy and subsequent risk of Parkinson's disease. Ann Neurol. 2015 Oct;78(4):522-9. doi: 10.1002/ana.24448. Epub 2015 Jul 17.
- Background: PubMed 31255487Kim S, Kwon SH, Kam TI, Panicker N, Karuppagounder SS, Lee S, Lee JH, Kim WR, Kook M, Foss CA, Shen C, Lee H, Kulkarni S, Pasricha PJ, Lee G, Pomper MG, Dawson VL, Dawson TM, Ko HS. Transneuronal Propagation of Pathologic alpha-Synuclein from the Gut to the Brain Models Parkinson's Disease. Neuron. 2019 Aug 21;103(4):627-641.e7. doi: 10.1016/j.neuron.2019.05.035. Epub 2019 Jun 26.
- Background: PubMed 31753762Cryan JF, O'Riordan KJ, Sandhu K, Peterson V, Dinan TG. The gut microbiome in neurological disorders. Lancet Neurol. 2020 Feb;19(2):179-194. doi: 10.1016/S1474-4422(19)30356-4. Epub 2019 Nov 18.
- Background: PubMed 33557896Aho VTE, Houser MC, Pereira PAB, Chang J, Rudi K, Paulin L, Hertzberg V, Auvinen P, Tansey MG, Scheperjans F. Relationships of gut microbiota, short-chain fatty acids, inflammation, and the gut barrier in Parkinson's disease. Mol Neurodegener. 2021 Feb 8;16(1):6. doi: 10.1186/s13024-021-00427-6.
- Background: PubMed 22145021Forsyth CB, Shannon KM, Kordower JH, Voigt RM, Shaikh M, Jaglin JA, Estes JD, Dodiya HB, Keshavarzian A. Increased intestinal permeability correlates with sigmoid mucosa alpha-synuclein staining and endotoxin exposure markers in early Parkinson's disease. PLoS One. 2011;6(12):e28032. doi: 10.1371/journal.pone.0028032. Epub 2011 Dec 1.
- 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.
Chiung-Chu Chen, PhD. principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation and Not received Fecal microbiota transplantation in people with Parkinson's Disease, run by Chang Gung Memorial Hospital.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siao-Chu Su, Bachelor (+886978835982, b9805039@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07597421, which also lists 30 linked publications.
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 19 May 2026.