Gut Microbiota and Tryptophan Metabolites in Parkinson's Disease
ConditionPARKINSON DISEASE (Disorder)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-90
SponsorNingxia Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Stool Microbiome and Targeted Tryptophan Metabolite Profiling
Diagnostic testEach 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Parkinson Disease Group1 intervention
Group B: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
Between-Group Differences in Fecal Tryptophan Metabolite Concentrations
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
Time frame
At enrollment, based on one stool sample collected from each participant2
Between-Group Difference in Fecal Microbial Community Structure
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
Time frame
At enrollment, based on one stool sample collected from each participantSponsors and contacts
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Source ClinicalTrials.gov
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