Xiqing plus probiotics to improve gut balance and drug effects in chronic kidney disease

The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease

This trial will test whether adding Xiqing and probiotics helps lower nitrogen waste and improve drug effectiveness in adults with stage 3–5 chronic kidney disease who are not on dialysis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07182942 on ClinicalTrials.gov

What this trial studies

Adults with CKD stage 3–5 who are not on dialysis will receive Xiqing (an adsorbent intended to remove nitrogenous waste) together with probiotic supplementation to try to modify intestinal homeostasis and influence drug effectiveness. The phase 4 interventional study is conducted at Tongji Hospital in Wuhan and follows patients through a treatment period with planned biochemical and clinical monitoring. Key outcomes will focus on nitrogen waste levels, kidney function markers (such as eGFR, creatinine, and urea), and changes in gut microbiota or metabolite profiles. Safety and tolerability of the combined regimen, including any adverse reactions to Xiqing or probiotics, will be tracked throughout the study.

Who should consider this trial

Good fit: Adults aged 18–75 with non-dialysis CKD stage 3–5 who are clinically stable, able to tolerate Xiqing and probiotics, and can provide informed consent are ideal candidates.

Not a fit: Patients who are on dialysis, have unstable vital signs or active severe infections, are pregnant or lactating, or who cannot tolerate Xiqing or probiotics are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the combination could reduce the burden of nitrogenous wastes, improve how well medications work, and potentially delay progression toward dialysis for some CKD patients.

How similar studies have performed: There is growing evidence that gut-targeted approaches (including probiotics) can affect nitrogen metabolism and CKD outcomes, but combining an adsorbent like Xiqing with probiotics in this context is relatively novel with limited prior direct trial data.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent was obtained;
2. ranging in age from 18 to 75 years;
3. CKD stage 3-5, that is, eGFR \< 60 mL/min/1.73 m2 with non-dialysis stage, no dialysis indication, temporarily stable condition and drug control stage;
4. tolerance of Xiqing and probiotics treatment.

Exclusion Criteria:

1. with severe active infection, influence of nutritional status in patients with malignant tumor and other diseases;
2. patients during pregnancy or lactation;
3. unstable vital signs, the condition is not stable, need dialysis patients;
4. patients with intolerance of Xiqing;
5. patients with intolerance of probiotics;
6. taking corticosteroids, antibiotics or other immunosuppressive agents within the past 3 months;
7. taking adsorbent drugs, such as medicinal charcoal tablets, within the past 3 months.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Chujin Cao, PhD

Conditions CKD; Drug Effect