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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease with Constipation | Experimental | Fecal microbiota transplantation will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Procedure | Fecal Microbiota Transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of clinical symptoms in patients with Parkinson's Disease will be assessed by the change of several scales of Parkinson's Disease. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongjian Zhou, MM | Contact | 86-13503060150 | eyzhouyongjian@scut.edu.cn | |
| Hongli Huang, MM | Contact | 86-13631316718 | honglisums@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongli Huang, MM | Guangzhou First People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32859778 | Background | 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. | |
| 32877215 | Background | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 31327219 | Background | 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. |
| 23225012 | Background | 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. |
| 31781020 | Background | 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. |
| 28805584 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |