Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About this trial
Investigating the differences in gut microbiota composition and tryptophan metabolite levels between kidney stone patients and healthy individuals, with special focus on:
1. Comparing the gut microbiota composition between kidney stone patients and healthy controls, with emphasis on analyzing the relative abundance of Lactobacillus salivarius 2. Comparing the differences in tryptophan metabolite levels such as indole-3-carboxylic acid (ICA) and kynurenine (Kyn) in serum between the two groups 3. Exploring the correlation between gut microbiota composition and tryptophan metabolite levels 4. Analyzing the influence of different environmental conditions (seasons, temperature and humidity) on gut microbiota and metabolite levels
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Inclusion criteria for patients with kidney stones
Age>=18 years;
Diagnosed with kidney stones by ultrasound, CT or urography;
Willing to provide stool samples and serum samples for study;
Disqualifiers
Use of antimicrobials or probiotics within the past 3 months;
Presence of active urinary tract infection;
Presence of other serious systemic diseases, such as hepatic or renal insufficiency, cardiac or pulmonary diseases, malignant tumors, and immunodeficiency states;
Congenital urinary tract abnormalities;
Trial population
Case group: Patients diagnosed with kidney stones Control group: Healthy volunteers without kidney stones
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
270 Participants
are grouped into 2 trial groupsGroup A: Kidney Stone Group
Group B: Healthy Control Group
Trial outcomes
Primary outcomes
1
Gut microbiota differences
Comparison of gut microbiota composition between the case and control groups, particularly the relative abundance of Lactobacillus salivarius. Unit of Measure: Relative abundance (unitless proportion)
Time frame
3 months postoperatively2
Serum indole-3-carboxylic acid (ICA) concentration and Serum kynurenine (Kyn) concentration
Comparison of serum ICA (indole-3-carboxylic acid) and Kyn (kynurenine) levels between the case and control groups. Unit of Measure: ng/mL.
Time frame
3 months postoperativelySecondary outcomes
1
Kynurenine to indole-3-carboxylic acid ratio (Kyn/ICA)
Evaluation of differences in tryptophan metabolism-related metabolites across groups, with a focus on changes in the Kyn/ICA ratio. Unit of Measure: Ratio (unitless).
Time frame
3 months postoperatively2
Spearman correlation coefficient between Lactobacillus salivarius abundance and serum ICA concentration
Unit of Measure: Correlation coefficient (ρ-value, unitless). Method: Spearman rank correlation analysis.
Time frame
3 months postoperatively3
Gut microbiota α-diversity
Unit of Measure: Diversity index (e.g., Shannon index, unitless). Method: 16S rRNA gene sequencing; multivariate linear regression
Time frame
3 months postoperatively4
Gut microbiota β-diversity
Unit of Measure: Dissimilarity index (e.g., Bray-Curtis, unitless). Method: 16S rRNA gene sequencing; PERMANOVA.
Time frame
3 months postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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