About this trial
This study aims to investigate the impact of probiotics and synbiotics on the nutritional status of patients with end-stage kidney disease (ESRD) who are undergoing hemodialysis. ESRD patients often face challenges such as poor nutritional status, increased risk of infections, and imbalances in gut microbiota. These challenges are made worse by the frequent use of medications, dietary restrictions, and the hemodialysis process itself, which can disturb the gut's natural bacteria balance.
Probiotics are live microorganisms that provide health benefits when taken in adequate amounts, while synbiotics are a combination of probiotics and prebiotics (substances that promote the growth of beneficial bacteria). The goal of this study is to explore whether supplementing ESRD patients with probiotics or synbiotics can improve their nutritional health, including aspects like body mass index (BMI), skin fold thickness, and protein metabolism.
The study will involve 60 patients from a hemodialysis center in Mansoura, Egypt. Patients will be randomly assigned to one of three groups: one group will receive probiotics, another will receive synbiotics, and the third group will act as a control (no treatment). The study will evaluate changes in nutritional markers and other health parameters before and after six months of supplementation.
This study hopes to provide insights into new, cost-effective interventions for improving the health of patients undergoing long-term dialysis treatment by addressing the question of whether these supplements can improve the nutritional status of hemodialysis patients.
Eligibility criteria
Qualifiers
Patients with End-Stage Renal Disease (ESRD) on regular hemodialysis (3 times per week).
Age 18 years or older.
Not prepared for kidney transplantation for more than 1 year.
Able and willing to provide written informed consent to participate in the study.
Disqualifiers
Patients who are actively preparing for kidney transplantation.
Pregnant or breastfeeding women.
Patients with active malignancy or undergoing cancer treatment.
Patients with known structural gastrointestinal (GI) disease (e.g., inflammatory bowel disease, severe gastrointestinal motility disorders).
Trial design
Treatments tested in this trial
- Lactogemikan (Probiotic Supplement)
- Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)