Probiotics ameliorate the hydrogen peroxide-induced epithelial barrier disruption by a PKC- and MAP kinase-dependent mechanism.
A Seth, Fang Yan, D Brent Polk...
https://pubmed.ncbi.nlm.nih.gov/18292183Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06863194
Effects of Probiotic Supplementation on Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease: A Randomized Controlled Trial
Led by Mansoura University · Updated on 2025-05-16
72
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether probiotic supplementation can slow the progression of moderate to severe chronic kidney disease (CKD) by improving kidney function and reducing inflammation and harmful toxins. This randomized, double-blind, placebo-controlled trial aims to assess the safety and effectiveness of probiotics in patients with CKD stages III and IV. The study also explores how probiotics affect gut microbiota composition and metabolic imbalances related to CKD. Participants will be randomly assigned to one of two groups: one group will receive a daily probiotic tablet containing 10 billion CFU of Lactobacillus plantarum for 6 months, while the other group will receive a placebo tablet identical in appearance and taste. After the 6-month treatment period, both groups will be followed for an additional 6 months without treatment to observe any lasting effects. The study involves regular clinical visits and laboratory tests to monitor treatment impact. During the study, participants will attend clinic visits at baseline, 6 months, and 12 months for checkups including blood and urine tests to measure kidney function, inflammation markers, and gut-derived toxins. Researchers will track changes in serum creatinine, estimated glomerular filtration rate (eGFR), urinary protein, and systemic inflammation markers like C-reactive protein and ferritin. Safety and tolerability of the probiotic supplementation will also be assessed throughout the trial, which lasts a total of 12 months per participant.
CONDITIONS
Brief Title
Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 24 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants take one tablet daily of either probiotic supplementation or placebo for 6 months to evaluate effects on kidney function, inflammation, and gut microbiota.
3 visits (baseline, 6 months, and 12 months)
Follow-up
Duration - 6 months
Participants are monitored for an additional 6 months after treatment to assess any lasting effects of the probiotic supplementation.
1 visit at 12 months
Trial Site Locations
Total: 1 location
1
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahliya, Egypt, 35111
Actively Recruiting
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Research Team
S
Samar Elshahat Saleh
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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Published Research Related To This Trial
Use of probiotics in patients with chronic kidney disease on hemodialysis: a randomized clinical trial.
Érica Maria Rodrigues de Araújo, Gdayllon Cavalcante Meneses, Antônio Augusto Ferreira Carioca...
https://pubmed.ncbi.nlm.nih.gov/36112723Effect of probiotics on human blood urea levels in patients with chronic renal failure.
Paola Vanessa Miranda Alatriste, Rocío Urbina Arronte, Cristóbal Obet Gómez Espinosa...
https://pubmed.ncbi.nlm.nih.gov/24559003The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease.
Na Tian, Lu Li, Jack Kit-Chung Ng...
https://pubmed.ncbi.nlm.nih.gov/36235699