NCT04819217Recruiting
Study of Oral Uremic Toxin Absorbent and Probiotics to Retard the Progression of Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In patients with chronic kidney disease (CKD), uremic toxins accumulate when kidney function declines. Those uremic toxins had a greater affinity to circulating proteins are called "protein bound uremic toxins, PBUT." Apart from traditional small or middle molecule uremic toxins, the PBUTs can be rarely eliminated using traditional renal replacement therapy, even using high flux dialysis modalities. Among these molecules identified, indoxyl sulfate (IS), and p-cresol (PC) are mostly studied. Both in vitro and in vivo study, IS and PC are associated with endothelial dysfunction, vascular smooth muscle proliferation, and increased risk for CV outcomes. The uremic toxins (IS and PC) are originated in the endogenous environment, mainly from the protein metabolism, food intake, or produced by gut microbiota. Prevention of IS or PC precursors from being absorbed across the intestinal tract has been extensively studied in the renal literature by use of oral adsorbents. In animal models, activated charcoal reduces the serum concentration of creatinine (cre) and may delay CKD progression by alleviating IS overload. An oral form of non-absorbable surface-modified activated bamboo charcoal (ABC), has been demonstrated to effectively reduce circulating and renal IS levels in animal models. Recently, probiotics, prebiotics or synbiotics have been reported to reduce inflammation, improve kidney function and retard progression of CKD by restoring the symbiosis of gut microflora in patients with CKD. A randomized trial found synbiotics decreased serum PCS without reducing serum IS in non-dialysis CKD. Another study found that synbiotics delayed CKD progression. A systematic review found prebiotic and probiotic therapies reduced IS and PCS in patients with end stage kidney disease (ESKD) on haemodialysis. However, it is unclear whether the results hold true for other patients with CKD. Based on these previous findings, investigators will conduct a prospective randomized open blinded end-point (PROBE) study to see if oral uremic toxin absorbent + probiotics prevent CKD progression. Also, a panel of clinical and biochemical profiles will be checked to investigate possible link between several biomarkers and clinical response.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 19 May 2020
- Start date
- 1 May 2020
- Primary completion date
- 1 Dec 2030
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT04819217
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 May 2020 to the primary completion date, 1 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastrointestinal operation.
- Solid organ or hematological transplantation recipients.
- Antibiotics or probiotics treatment within the last 2 weeks before enrollment and during follow-up period.
Other illness
- Peptic ulcer, esophageal varices, ileus or under fasting status
- Patients with major hemorrhage, as defined with acute hemorrhage and requirement of blood transfusion during index admission.
- Evidence of obstructive kidney injury or polycystic kidney disease.
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening.
Lab values
- Baseline estimated glomerular filtration rates (eGFR) \< 15 ml/min/1.73m2 according to MDRD equation.
- Patients in severe malnutrition status, albumin less than 2.0 g/dL
- Patients in severe anemia or active gastrointestinal bleeding with hemoglobulin \< 8 g/dL.
Other
- 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.
- Patients with a biopsy proved or clinically diagnosed advanced liver cirrhosis, Child classification B or C.
- Patients with oliguric kidney injury, as defined with less than 500 cc/day.
Who the study is looking for
- Age ≥ 20 years old on the day of screening.
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NTUH Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.