Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Recruiting · NCT06863194 · Interventional (participants receive a specific treatment) · Lead sponsor: Mansoura University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn whether probiotic supplementation can slow disease progression in patients with moderate to severe chronic kidney disease (CKD). The trial will also assess the safety of probiotics in these patients. The main questions the study aims to answer are: Does probiotic supplementation improve kidney function by reducing serum creatinine levels and protein in urine? Does it reduce inflammation and metabolic imbalances in CKD patients? Does it affect gut microbiota composition and lower harmful toxins in the body? Is probiotic supplementation safe and well-tolerated in CKD patients? Participants will: Be randomly assigned to receive either probiotics or a placebo for 6 months. Have clinic visits every 6 months for checkups, blood tests, and urine tests. Be monitored for any side effects and changes in kidney function. Researchers will compare the probiotic group to the placebo group to determine whether probiotics are effective in slowing CKD progression.
Who can take part
Inclusion criteria
- Adults aged ≥ 18 years (both males and females).
- Diagnosed with Chronic Kidney Disease (CKD) Stage III or IV, confirmed by eGFR.
- Stable medical condition with no recent hospitalization for acute kidney injury or other serious illnesses.
- Not currently on probiotic supplementation or prebiotic therapy.
- Willing to provide informed consent and comply with the study protocol, including clinic visits and sample collection.
Exclusion criteria
- CKD Stage I, II, or V, or on dialysis.
- Currently using probiotics or prebiotics as part of their diet or treatment.
- History of active malignancy (cancer) or undergoing chemotherapy.
- Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery).
- Pregnant or breastfeeding women (due to safety concerns).
- Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis).
- Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition.
- Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol.
Where it is running
1 location listed.
- Urology and Nephrology Center, Mansoura University - Al Mansurah, Dakahliya, Egypt