Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway

NCT07043374 | Not Yet Recruiting

• 1 other identifier: IIT2025-059
• Study Type: observational
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigating the differences in gut microbiota composition and tryptophan metabolite levels between kidney stone patients and healthy individuals, with special focus on:

1. 1.Comparing the gut microbiota composition between kidney stone patients and healthy controls, with emphasis on analyzing the relative abundance of Lactobacillus salivarius
2. 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. 3.Exploring the correlation between gut microbiota composition and tryptophan metabolite levels
4. 4.Analyzing the influence of different environmental conditions (seasons, temperature and humidity) on gut microbiota and metabolite levels

Conditions

Kidney Calculi; Ureteral Calculi

Outcome Measures

Primary Outcomes (2)

• 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)

  3 months postoperatively

• 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.

  3 months postoperatively

Secondary Outcomes (8)

• Kynurenine to indole-3-carboxylic acid ratio (Kyn/ICA)

  3 months postoperatively

• Spearman correlation coefficient between Lactobacillus salivarius abundance and serum ICA concentration

  3 months postoperatively

• Gut microbiota α-diversity

  3 months postoperatively

• Gut microbiota β-diversity

  3 months postoperatively

• Relative abundance of Lactobacillus salivarius

  3 months postoperatively

Study Arms (2)

Kidney Stone Group

Patients diagnosed with kidney stones via imaging examinations (ultrasound, CT, or urography) were recruited from both outpatient clinics and inpatient departments of the Urology Department at our hospital.

Healthy Control Group

1. Recruit healthy volunteers confirmed by imaging examinations to be free of kidney stones from our hospital's Physical Examination Center. 2. Recruit patients with no history of kidney diseases from other departments of our hospital (e.g., Department of Orthopedics, Department of General Surgery). 3. Recruit healthy volunteers through community outreach, confirmed by ultrasound examination to be free of kidney stones.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Case group: Patients diagnosed with kidney stones Control group: Healthy volunteers without kidney stones

You may qualify if:

• Age\>=18 years;
• Diagnosed with kidney stones by ultrasound, CT or urography;
• Willing to provide stool samples and serum samples for study;
• No history of antimicrobial use in the past 3 months;
• Signed and dated informed consent indicating that the patient or his/her legal representative is fully informed of the study-related information and agrees to participate.
• Age\>=18 years;
• No history of kidney stones and family history;
• Imaging examination (such as abdominal ultrasound) showed no kidney stones;
• Willing to provide stool samples and serum samples for research;
• No history of antibiotic use in the past 3 months;
• Signed and dated informed consent indicating that the volunteer is fully informed about the study-related information and agrees to participate.

You may not qualify if:

• 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;
• Previous history of kidney transplantation or urinary diversion surgery;
• Pregnant or lactating women;
• Presence of chronic intestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, etc.;
• Inability to provide samples or complete follow-up according to the research protocol;
• Participation in other clinical studies within the past 3 months;
• Other conditions deemed unsuitable for participation in this study by the researcher.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Kidney Calculi; Ureteral Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Diseases

Study Officials

• Shao Yi

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhu Ruixuan

CONTACT

+86 13780820139; luluzhu2023@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 29, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01