Probiotic supplementation to slow kidney disease progression
Effects of Probiotic Supplementation on Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease: A Randomized Controlled Trial
This study is testing if taking probiotics can help people with moderate to severe chronic kidney disease feel better and slow down the progression of their condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Al Mansurah, Dakahliya) |
| Trial ID | NCT06863194 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether probiotic supplementation can slow the progression of moderate to severe chronic kidney disease (CKD) by improving kidney function, reducing inflammation, and altering gut microbiota composition. Participants will be randomly assigned to receive either probiotics or a placebo for six months, with regular clinic visits for monitoring kidney function and potential side effects. The study aims to determine the safety and efficacy of probiotics in reducing harmful uremic toxins and improving overall health in CKD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with moderate to severe chronic kidney disease (Stages III-IV).
Not a fit: Patients with early-stage CKD (Stages I or II), those on dialysis, or individuals with significant gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to slow the progression of chronic kidney disease and improve patient outcomes.
How similar studies have performed: While some previous studies have shown inconsistent results regarding probiotics in CKD, this trial aims to provide clearer insights into their efficacy, making it a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Al Mansurah, Dakahliya
- Urology and Nephrology Center, Mansoura University — Al Mansurah, Dakahliya, Egypt (Recruiting)
Study contacts
- Study coordinator: Samar Elshahat Saleh
- Email: samarelshahat@mans.edu.eg
- Phone: 00201023771331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.