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Gut Microbiota and Tryptophan Metabolites in Parkinson's Disease

1 augustus 2026 bijgewerkt door: Hanqing Guo, Ningxia Medical University

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

30

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Shandong
      • Laizhou, Shandong, China, 261400
        • Laizhou People's Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Thirty participants will be enrolled in this single-center observational study, including 15 participants with Parkinson disease and 15 individually matched healthy controls. Participants with Parkinson disease will be recruited from neurology outpatient or inpatient services. Healthy controls may be recruited from health-screening programs, the community, or non-cohabiting relatives. Each healthy control will be matched to a participant with Parkinson disease by sex, age within 5 years, and body mass index within 3 kg/m^2. All participants will provide clinical and lifestyle information and one stool sample.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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
Diagnostische toets: Stool Microbiome and Targeted Tryptophan Metabolite Profiling
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.
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
Diagnostische toets: Stool Microbiome and Targeted Tryptophan Metabolite Profiling
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Between-Group Differences in Fecal Tryptophan Metabolite Concentrations
Tijdsspanne: At enrollment, based on one stool sample collected from each participant
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
At enrollment, based on one stool sample collected from each participant
Between-Group Difference in Fecal Microbial Community Structure
Tijdsspanne: At enrollment, based on one stool sample collected from each participant
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
At enrollment, based on one stool sample collected from each participant

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ningxia Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 augustus 2026

Primaire voltooiing (Geschat)

20 oktober 2026

Studie voltooiing (Geschat)

20 november 2026

Studieregistratiedata

Eerst ingediend

1 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 augustus 2026

Eerst geplaatst (Werkelijk)

6 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

1 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0570

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

No public sharing of individual participant data is currently planned. Aggregate study results will be reported in scientific publications. Any future sharing of de-identified participant-level data would require confirmation of compatibility with participant consent, ethics approval, and an appropriate data-use agreement

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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