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Parkinson's DiseaseNCT04837313

Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation

A study testing Fecal Microbiota Transplantation in people with Parkinson's Disease and Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Parkinson's disease(PD) may cause the autonomic nervous system's improper functioning, which is responsible for regulating the intestinal tract movement. A certain degree of degeneration of digestive system function can cause PD patients to constipation symptoms. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Fecal Microbiota Transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 May 2021to 30 Dec 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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18-75 years of age
  • Signed informed consent form
  • Clinical diagnosis of Parkinson's disease (according to 2016 edition of Chinese Parkinson's disease diagnostic criteria)
  • Parkinson's disease duration of 1 year or more
  • Hoehn \& Yahr stage 1-4 (including)
  • Patients have following 2 or more symptoms, which appear for at least 6 months and exist in recent 3 months: A. at least 25% of defecation feel strenuous; B. At least 25% of defecation was not massive or hard; C. at least 25% of defecation had incomplete feeling; D. at least 25% of defecation had anorectal obstruction; E. at least 25% of defecation needed manual assistance; F. defecation less than 3 times a week, with or without abdominal pain
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  • Patients are taking oral L-dopa (with or without Benserazide, carbidopa, and O-methyltransferase inhibitors) at least 4 weeks, and be able to tolerate a steady dose of dopamine agonists, monoamine oxidase B inhibitors, anticholinergics, and / or adamantine.
  • Patients are taking stable dosage of anti-PD drugs, antidepressant drugs and antipsychotics for more than 1 month.
  • Be able to tolerate the FMT infusion method such as endoscopy, colonoscopy, capsule, nasoduodenal tube insertion, etc.
  • Be able to receive follow-up visit, follow-up examination and specimen collection on time

Who cannot join

  • Patients with Parkinson's syndrome and Parkinsonism plus syndrome
  • History of cerebrovascular accident, brain injury, epilepsy and other brain injury
  • The "opening" stage was Hoehn \& Yahr 5
  • Patient received neurosurgical intervention or stereotactic brain surgery for Parkinson's disease
  • Patients with organic lesions of digestive tract
  • Patients had major abdominal surgery
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  • History of infectious diarrhea and took antibiotics in recent 2 weeks
  • Patients infected with Clostridium difficile and other pathogens
  • Patients with HIV or compromised immune system (such as congenital immunodeficiency or currently taking immunosuppressive drugs)
  • Patients with uncontrollable basic diseases of digestive system
  • Patients could not fully understand and sign the informed consent form
  • Patients who were not considered suitable for inclusion in the study

Trial locations and contacts

1 site in 1 country.

Yongjian Zhou, MM contact

86-13503060150

eyzhouyongjian@scut.edu.cn

Hongli Huang, MM contact

86-13631316718

honglisums@126.com

China1 site, 1 recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

    Yongjian Zhou, MM, 86-13503060150, eyzhouyongjian@scut.edu.cn

    Hongli Huang, MM, 86-13631316718, honglisums@126.com

    Recruiting

Other trials in China

About this study

Parkinson's disease(PD) may cause the autonomic nervous system's improper functioning, which is responsible for regulating the intestinal tract movement. A certain degree of degeneration of digestive system function can cause PD patients to constipation symptoms. Studies have shown that up to 63 percent of people with Parkinson's disease experience constipation. What is more, medications for PD, including levodopa and dopamine agonist, can also cause constipation. In recent years, an increasing number of studies have been conducted to investigate gut microflora and their influence on the central nervous system. Furthermore, some studies of Parkinson's disease have confirmed that gut microflora plays a vital role in the occurrence and development of Parkinson's disease.

The purpose of this study is to evaluate the efficacy and safety of fecal microbiota transplantation in the treatment of constipation symptoms in patients with Parkinson's disease receiving a steady dose of levodopa. We will also analyze intestinal flora diversity in patients with Parkinson's disease with constipation. The investigation of the gut microbiome may emerge as a new therapeutic measure to treat constipation associate with Parkinson's disease.

Being tested
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

    Fecal Microbiota Transplantation

Study groups in NCT04837313
Study groupRoleWhat they receive
Parkinson's Disease with ConstipationExperimentalFecal microbiota transplantation will be performed.
Receives: Procedure: Fecal Microbiota Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Efficacy of FMT in patients with constipation will be assessed by the change of The Gastrointestinal Symptom Rating Scale (GSRS) and Wexner Constipation Score.

    The data will be collected in several time points from baseline to 6 months after FMT. Gastrointestinal Symptom Rating Scale(GSRS) is a measure of gastrointestinal symptom severity in five clusters (pain, bloating, constipation, diarrhea, and early satiety).The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom.

    Wexner Constipation Scoring system is a scale to evaluate the severity of constipation. These factors included frequency of bowel movements, painful evacuation, incomplete evacuation, abdominal pain, length of time per attempt, assistance for evacuation, unsuccessful attempts for evacuation per 24 hours, and duration of constipation, with 0 indicating normal and 30 indicating severe constipation.

    Measured: 6 months

Secondary outcomes (1)

  1. The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start1 May 2021
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837313
Sponsor's protocol ID
K-2020-107-02
Status last verified
Oct 2020
First submitted
20 Dec 2020
Last updated
3 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baizabal-Carvallo JF. Gut microbiota: a potential therapeutic target for Parkinson's disease. Neural Regen Res. 2021 Feb;16(2):287-288. doi: 10.4103/1673-5374.290896. No abstract available.

    PubMed 32859778

  • Bhattarai Y, Kashyap PC. Parkinson's disease: Are gut microbes involved? Am J Physiol Gastrointest Liver Physiol. 2020 Nov 1;319(5):G529-G540. doi: 10.1152/ajpgi.00058.2020. Epub 2020 Sep 2.

    PubMed 32877215

  • Dutta SK, Verma S, Jain V, Surapaneni BK, Vinayek R, Phillips L, Nair PP. Parkinson's Disease: The Emerging Role of Gut Dysbiosis, Antibiotics, Probiotics, and Fecal Microbiota Transplantation. J Neurogastroenterol Motil. 2019 Jul 1;25(3):363-376. doi: 10.5056/jnm19044.

    PubMed 31327219

  • Mhyre TR, Boyd JT, Hamill RW, Maguire-Zeiss KA. Parkinson's disease. Subcell Biochem. 2012;65:389-455. doi: 10.1007/978-94-007-5416-4_16.

    PubMed 23225012

  • Yang D, Zhao D, Ali Shah SZ, Wu W, Lai M, Zhang X, Li J, Guan Z, Zhao H, Li W, Gao H, Zhou X, Yang L. The Role of the Gut Microbiota in the Pathogenesis of Parkinson's Disease. Front Neurol. 2019 Nov 6;10:1155. doi: 10.3389/fneur.2019.01155. eCollection 2019.

    PubMed 31781020

  • Stocchi F, Torti M. Constipation in Parkinson's Disease. Int Rev Neurobiol. 2017;134:811-826. doi: 10.1016/bs.irn.2017.06.003. Epub 2017 Jul 13.

    PubMed 28805584

Questions about this trial

What is this clinical trial studying?

A study testing Fecal Microbiota Transplantation in people with Parkinson's Disease and Fecal Microbiota Transplantation, run by Guangzhou First People's Hospital at 1 site in China.

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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. 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 China. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongjian Zhou, MM (86-13503060150, eyzhouyongjian@scut.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Efficacy of FMT in patients with constipation will be assessed by the change of The Gastrointestinal Symptom Rating Scale (GSRS) and Wexner Constipation Score. (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 NCT04837313, which also lists 6 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 3 Aug 2021.

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