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Probiotic Supplementation and Disease Progression in CKD: A Randomized Trial

NCT06863194 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Probiotic 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.

DRUG

Placebo 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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-03
Primary Completion
2025-10-03
Completion
2025-10-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863194 on ClinicalTrials.gov