NCT06863194 Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
| NCT ID | NCT06863194 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Mansoura University |
| Condition | Kidney Disease, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2025-10-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2025-04-03 with a primary completion date of 2025-10-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06863194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Disease, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06863194 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06863194 currently recruiting?
Yes, NCT06863194 is actively recruiting participants. Contact the research team at samarelshahat@mans.edu.eg for enrollment information.
Where is the NCT06863194 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT06863194 clinical trial?
NCT06863194 is sponsored by Mansoura University. The trial plans to enroll 72 participants.
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