Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic Supplementation (Lactobacillus plantarum)
DrugParticipants 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.
Placebo Tablets
DrugParticipants 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Arm 1 (Intervention Group) Arm Title: Probiotic Supplementation Group Description: Participants in tExperimental treatment 1 intervention
Group B: Arm 2 (Control Group) Arm Title: Placebo Group Description: Participants in this group will receivePlacebo comparator 0 interventions
Trial outcomes
Primary outcomes
1
Change in Estimated Glomerular Filtration Rate (eGFR)
eGFR will be calculated using the CKD-EPI 2021 equation to assess changes in kidney function over time. A slower decline in eGFR in the probiotic group compared to the placebo group would indicate a beneficial effect.
Time frame
Baseline, and 6 monthsSecondary outcomes
1
Change in Gut-Derived Uremic Toxins (Indoxyl Sulfate)
Urinary indican (indoxyl sulfate) levels will be measured to assess whether probiotics alter gut microbiota composition and reduce uremic toxin production.
Time frame
Baseline, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov