Actively Recruiting
Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Led by Mansoura University · Updated on 2025-05-16
72
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 63; 18 years (both males and females)
- Diagnosed with Chronic Kidney Disease Stage III or IV, confirmed by eGFR
- Stable medical condition with no recent hospitalization for acute kidney injury or serious illnesses
- Not currently using probiotic or prebiotic supplements
- Willing to provide informed consent and follow the study protocol including clinic visits and sample collections
You will not qualify if you...
- Chronic Kidney Disease Stage I, II, or V, or currently on dialysis
- Currently using probiotics or prebiotics as part of diet or treatment
- History of active cancer or undergoing chemotherapy
- Significant gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, or recent GI surgery
- Pregnant or breastfeeding women
- Diagnosis of autoimmune diseases like lupus or rheumatoid arthritis
- On long-term antibiotic or anti-inflammatory medications that could affect gut microbiota
- Severe behavioral or cognitive disorders preventing study adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahliya, Egypt, 35111
Actively Recruiting
Research Team
S
Samar Elshahat Saleh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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