NCT06863194RecruitingPhase 1/2
Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Effects of Probiotic Supplementation on Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 3 Mar 2025
- Start date
- 3 Apr 2025
- Primary completion date
- 3 Oct 2025
- Lead sponsor
- Mansoura University
- Diseases
- Chronic kidney disease
- NCT number
- NCT06863194
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 72
- From 3 Apr 2025 to the primary completion date, 3 Oct 2025
- 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
- Currently using probiotics or prebiotics as part of their diet or treatment.
- Individuals on long-term antibiotic or anti-inflammatory medication that could interfere with microbiota composition.
Other illness
- History of active malignancy (cancer) or undergoing chemotherapy.
- Significant gastrointestinal disease (e.g., inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery).
- Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis).
- Individuals with severe behavioral or cognitive disorders that may prevent adherence to the study protocol.
Other
- CKD Stage I, II, or V, or on dialysis.
- Pregnant or breastfeeding women (due to safety concerns).
Who the study is looking for
- 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.
Age in the registry: 18 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 |
|---|---|---|---|
| Urology and Nephrology Center, Mansoura University Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.