Oral uremic toxin absorbent and probiotics to lower inflammation and slow diabetic kidney disease

Study of Oral Uremic Toxin Absorbent/Probiotics to Modulate Systemic Inflammation and Retard the Progression of Chronic Kidney Disease in Patients With Diabetes.

This trial tests whether an oral toxin absorbent alone or combined with probiotics can reduce systemic inflammation and slow kidney decline in adults with diabetes-related chronic kidney disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei, Taiwan)
• Trial ID: NCT07333313 on ClinicalTrials.gov

What this trial studies

Adults with diabetic kidney disease and stable renal function will be enrolled at National Taiwan University Hospital and assigned to receive an oral uremic toxin absorbent, probiotics, or the combination. The absorbent (activated charcoal–type) is intended to bind gut-derived uremic toxins while probiotics aim to favorably alter gut microbiota and toxin production. Participants are stratified by baseline eGFR into four groups spanning mild to severe CKD and will have inflammatory markers, p-cresyl sulfate (PCS) levels, creatinine/eGFR, and clinical outcomes monitored over time. Safety exclusions include active gastrointestinal disease, recent GI surgery, severe malnutrition or anemia, and chronic constipation.

Who should consider this trial

Good fit: Adults over 20 with diabetes and diabetic kidney disease who have stable renal function and PCS levels, fitting one of the trial eGFR strata (approximately 45–60, 30–45, 15–30, or <15 ml/min/1.73 m2) and who are not pregnant are the intended participants.

Not a fit: Patients with severe malnutrition (albumin <2.0 g/dL), severe anemia (hemoglobin <8 g/dL), active peptic ulcer/esophageal varices/ileus or active GI bleeding, recent major GI surgery, chronic constipation (<3 bowel movements/week), or baseline eGFR >90 ml/min/1.73 m2 are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce circulating uremic toxins and inflammation, potentially slowing progression of diabetic kidney disease and lowering cardiovascular risk.

How similar studies have performed: Preclinical studies and some small clinical observations have suggested activated charcoal and certain probiotics can lower gut-derived uremic toxins and inflammation, but large randomized data demonstrating clinical benefit are limited.

Eligibility criteria

Inclusion Criteria:

1. Age \> 20 years old but not pregnant on the day of screening.
2. DKD patients with stable renal function (Cre elevation \< 0.3 mg/dL for at least 30 days) and PCS level (fluctuation \< 10% for at least 30 days)
3. Group 1: 120 DKD patients with 45\<eGFR\<60 ml/min/1.73m2 in stable status. Group 2: 120 DKD patients with 30\<eGFR\<45 ml/min/1.73m2 in stable status. Group 3: 60 DKD patients with 15\<eGFR\<30 ml/min/1.73m2 in stable status Group 4: 60 DKD patients with eGFR\<15 ml/min/1.73m2 in stable status

Exclusion Criteria:

1. Baseline eGFR \> 90 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. Active 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.
7. Incomplete evacuation and inability to pass stool. If usage of oral laxatives can achieve bowel movement, this patient will not be excluded.
8. Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
9. Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
10. Solid organ or hematological transplantation recipients.
11. Evidence of obstructive kidney injury or polycystic kidney disease.
12. Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
13. Patients with Immune Deficiency Syndrome.
14. Antibiotics or probiotics treatment within the last 3 months before enrollment and during follow-up period.

Where this trial is running

Taipei, Taiwan

• National Taiwan University Hospital. — Taipei, Taiwan, Taiwan (Recruiting)

Study contacts

• Study coordinator: chauchung wu, PhD

Conditions Oral Uremic Toxin Absorbent