Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Probiotic Supplementation (Lactobacillus plantarum)
  • Placebo Tablets

Treatment groups

72 Participants
are divided into 2 treatment groups

Locations

1
Urology and Nephrology Center, Mansoura University35111, Al MansurahDakahliya, Egypt

Sponsors and collaborators

Mansoura University

Lead sponsor

Source ClinicalTrials.gov