Using oral absorbents and probiotics to slow down chronic kidney disease progression

Study of Oral Uremic Toxin Absorbent and Probiotics to Retard the Progression of Chronic Kidney Disease

This study is testing whether a special charcoal and probiotics can help slow down kidney problems and improve health for people with chronic kidney disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT04819217 on ClinicalTrials.gov

What this trial studies

This study investigates the use of an oral uremic toxin absorbent, specifically activated bamboo charcoal, alongside probiotics to reduce the levels of harmful uremic toxins in patients with chronic kidney disease (CKD). The approach aims to prevent the absorption of these toxins, which are linked to kidney function decline and cardiovascular risks. By targeting protein-bound uremic toxins like indoxyl sulfate and p-cresol, the study seeks to improve kidney function and overall health outcomes for CKD patients. Participants will be monitored for changes in kidney function and toxin levels throughout the intervention.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 and older with chronic kidney disease and specific eGFR and UACR levels.

Not a fit: Patients with severe kidney impairment (eGFR < 15 ml/min/1.73m2) or those with significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly slow the progression of chronic kidney disease and improve patients' quality of life.

How similar studies have performed: Previous studies have shown promise in using oral absorbents and probiotics to manage uremic toxins, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 20 years old on the day of screening.
2. CKD patients with eGFR 15 \< eGFR \<45 ml/min/1.73m2 and UACR \> 100 mg/g in a stable status, creatinine elevated less than 0.3 mg/dL in at least 30 days before enrollment.

Exclusion Criteria:

1. Baseline estimated glomerular filtration rates (eGFR) \< 15 ml/min/1.73m2 according to MDRD equation.
2. Patients in severe malnutrition status, albumin less than 2.0 g/dL
3. Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL.
4. Peptic ulcer, esophageal varices, ileus or under fasting status
5. Previous gastrointestinal operation.
6. Chronic constipation, as defined with less than 3 bowel movements per week, straining, hard stools, incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.
7. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
8. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
9. Solid organ or hematological transplantation recipients.
10. Patients with oliguric kidney injury, as defined with less than 500 cc/day.
11. Evidence of obstructive kidney injury or polycystic kidney disease.
12. Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
13. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.

Where this trial is running

Taipei

• Ntuh — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Chau chung Wu, Ph.D. — National Taiwan University Hospital
• Study coordinator: Chau chung Wu, Ph.D.

Conditions CKD; CKD oral absorbent probiotics LncRNA, gut microbiota