RecruitingPhase 1Phase 2NCT06863194

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

Sponsor

Mansoura University

Enrollment

72 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Disease, Chronic Renal Insufficiency, Chronic Gut Dysbiosis Uremic Toxins

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.

Interventions

DRUGProbiotic Supplementation (Lactobacillus plantarum)

Participants in this group will receive Lactogemikan (Probiotic Supplement), which contains 10 billion CFU of Lactobacillus plantarum per tablet. The dose is one tablet daily for 6 months. This probiotic is intended to modulate gut microbiota, reduce systemic inflammation, and decrease uremic toxins (indoxyl sulfate) in CKD patients. The intervention will be compared to a placebo to evaluate its effectiveness in slowing CKD progression and improving metabolic and inflammatory markers.

DRUGPlacebo Tablets

Participants in this group will receive an inert placebo tablet that is identical in appearance, taste, and packaging to the probiotic supplement but contains no active probiotic ingredients. The dose is one tablet daily for 6 months. The placebo serves as a control to compare the effects of the probiotic intervention. Both groups will undergo identical monitoring and follow-up assessments to determine whether the probiotic has a significant effect on kidney function, inflammation, and gut microbiota composition.