Gut Microbiota and Tryptophan Metabolites in Parkinson's Disease
An Exploratory Case-Control Study of Fecal Microbiota and Targeted Tryptophan Metabolite Profiling in Patients With Parkinson's Disease
Parkinson's disease is a progressive neurological disorder that can also affect the digestive system. Changes in gut microorganisms and tryptophan metabolites may be associated with Parkinson's disease, but these relationships are not fully understood. This exploratory observational study will compare gut microbial communities and targeted tryptophan metabolite profiles between 15 participants with Parkinson's disease and 15 healthy controls matched by sex, age, and body mass index.
Each participant will provide clinical and lifestyle information and one stool sample. Stool samples will be analyzed using 16S ribosomal RNA gene sequencing and targeted liquid chromatography-tandem mass spectrometry. The study will evaluate differences in gut microbial composition and selected tryptophan metabolites and explore their associations with constipation, bowel habits, medication use, and clinical features of Parkinson's disease. No treatment will be assigned, and participants' usual medical care will not be changed. The findings are exploratory and are intended to guide larger future studies; they cannot establish causality or be used to diagnose Parkinson's disease.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: qinghan Guo
- Telefonní číslo: 86+17753626689
- E-mail: ghqnxykd@163.com
Studijní místa
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Shandong
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Laizhou, Shandong, Čína, 261400
- Laizhou People's Hospital
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Kontakt:
- Xiumei Gong
- Telefonní číslo: +8618553631703
- E-mail: 18553631703@163.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Participants aged 45 to 90 years, of any sex. Participants able to understand the study, provide written informed consent, and provide an acceptable stool sample according to the study procedures.
For the Parkinson disease group: clinically established or clinically probable Parkinson disease diagnosed by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria.
For the Parkinson disease group: preferably a disease duration of 5 years or less and Hoehn-Yahr stage I to III.
For the Parkinson disease group: stable antiparkinsonian medication regimen for at least 4 weeks before enrollment.
For the healthy control group: no history of Parkinson disease, parkinsonism, or another neurodegenerative disorder and no evident parkinsonian symptoms at screening.
Healthy controls matched individually to participants with Parkinson disease by sex, age within 5 years, and body mass index within 3 kg/m^2
Exclusion Criteria:
- Use of systemic antibiotics within 3 months before stool collection. Use of probiotics, prebiotics, tryptophan, 5-hydroxytryptophan, live biotherapeutic products, or other microbiome-related supplements within 4 weeks before stool collection.
Acute infection, fever, acute diarrhea, gastroenteritis, colonoscopy preparation, or a major dietary change within 4 weeks before stool collection.
Active inflammatory bowel disease, celiac disease, short-bowel syndrome, gastrointestinal malignancy, or major gastrointestinal surgery within 6 months.
Active cancer, decompensated liver or kidney disease, severe cardiovascular or hematological disease, active autoimmune disease, or current systemic glucocorticoid or immunosuppressive treatment.
Pregnancy or breastfeeding. Long-term exclusive enteral or parenteral nutrition. Inability to provide an acceptable stool sample or essential clinical information.
Any other condition considered by the investigator to compromise participant safety, study adherence, or interpretation of the results.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Parkinson Disease Group
Participants aged 45 to 90 years with clinically established or clinically probable Parkinson disease.
Participants will provide clinical and lifestyle information and one stool sample for 16S ribosomal RNA gene sequencing and targeted tryptophan metabolite analysis.
No intervention will be assigned
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Each participant will provide one stool sample.
Separate aliquots will be analyzed using 16S ribosomal RNA gene amplicon sequencing and targeted liquid chromatography-tandem mass spectrometry to characterize the gut microbiota and quantify prespecified tryptophan metabolites.
These analyses are conducted for research purposes only and will not be used for clinical diagnosis or treatment decisions.
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Healthy Control Group
Healthy participants aged 45 to 90 years who are matched to the Parkinson disease group by sex, age, and body mass index.
Participants will provide clinical and lifestyle information and one stool sample for 16S ribosomal RNA gene sequencing and targeted tryptophan metabolite analysis.
No intervention will be assigned
|
Each participant will provide one stool sample.
Separate aliquots will be analyzed using 16S ribosomal RNA gene amplicon sequencing and targeted liquid chromatography-tandem mass spectrometry to characterize the gut microbiota and quantify prespecified tryptophan metabolites.
These analyses are conducted for research purposes only and will not be used for clinical diagnosis or treatment decisions.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Between-Group Differences in Fecal Tryptophan Metabolite Concentrations
Časové okno: At enrollment, based on one stool sample collected from each participant
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Fecal concentrations of tryptophan, kynurenine, kynurenic acid, quinolinic acid, indole-3-acetic acid, indole-3-lactic acid, indole-3-propionic acid, and tryptamine will be quantified using targeted liquid chromatography-tandem mass spectrometry.
Results will be reported as nanograms per gram or micromoles per kilogram of wet stool.
Matched between-group differences will be summarized using effect estimates, 95 percent confidence intervals, and Benjamini-Hochberg false discovery rate-adjusted results
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At enrollment, based on one stool sample collected from each participant
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Between-Group Difference in Fecal Microbial Community Structure
Časové okno: At enrollment, based on one stool sample collected from each participant
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Fecal microbial community structure will be characterized using Bray-Curtis and Aitchison beta-diversity metrics derived from 16S ribosomal RNA gene amplicon sequencing.
Differences between the Parkinson disease group and the matched healthy control group will be evaluated using permutational multivariate analysis of variance, with pair identification used to restrict permutations
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At enrollment, based on one stool sample collected from each participant
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-0570
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