Actively Recruiting
The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease
Led by Chujin Cao · Updated on 2025-09-19
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic kidney disease (CKD) is a major global health concern characterized by impaired kidney function leading to the buildup of nitrogen metabolic waste, which can cause multiple organ and cardiac complications. Researchers are investigating how Xiqing, a drug containing coated aldehyde oxystarch capsules with adsorption effects, influences intestinal homeostasis and drug efficacy in CKD patients. The study also explores whether combining Xiqing with probiotics, which have been shown to reduce blood urea nitrogen (BUN) levels and intestinal inflammation, can better regulate the gut environment and delay CKD progression. This clinical trial is a prospective, randomized, open-label study with blinded end-point evaluation involving three experimental groups: one receiving Xiqing alone, another receiving probiotics alone, and a third group receiving both Xiqing and probiotics. The interventions are given orally, and the study applies advanced techniques like microbial diversity analysis, metagenomics, and metabolomics to understand the effects on intestinal flora, intestinal mucosa function, and metabolites. Participants will be monitored over a period of three months to assess kidney disease progression and cardiovascular events. The study includes detailed data collection on multi-omics markers to analyze drug effects related to intestinal balance. Participants will undergo regular evaluations to track clinical outcomes and safety, contributing valuable insights into the relationship between intestinal health and drug response in CKD management.
CONDITIONS
Brief Title
The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Aged between 18 and 75 years
- Diagnosed with stage 3 to 5 chronic kidney disease (eGFR < 60 mL/min/1.73 m2), not on dialysis and with stable condition
- Able to tolerate treatment with Xiqing and probiotics
You will not qualify if you...
- Presence of severe active infection or conditions affecting nutritional status such as malignant tumors
- Currently pregnant or breastfeeding
- Unstable vital signs or requiring dialysis
- Intolerance to Xiqing
- Intolerance to probiotics
- Use of corticosteroids, antibiotics, or other immunosuppressive agents within the past 3 months
- Use of adsorbent drugs like medicinal charcoal tablets within the past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive oral interventions of Xiqing, probiotics, or a combination of both to assess their effect on chronic kidney disease.
Regular visits during the 3-month treatment period
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
C
Chujin Cao, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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