Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway (NCT07043374) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of Humid-Heat on Gut-Tryptophan-Stone Pathway
270 participantsStarted 2026-09-01
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* 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.
* Inclusion criteria for the healthy control group
* 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.
Exclusion Criteria:
* 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.;
* Inabi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut microbiota differences
Timeframe: 3 months postoperatively
2
Serum indole-3-carboxylic acid (ICA) concentration and Serum kynurenine (Kyn) concentration
Timeframe: 3 months postoperatively
Trial details
NCT IDNCT07043374
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine