Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06863194

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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