Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients

Summary

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.

Conditions

• Hemodialysis
• Probiotics
• Synbiotics
• Nutritional Status

Interventions

DIETARY_SUPPLEMENT

Lactogemikan (Probiotic Supplement)

This intervention involves daily supplementation of Lactogemikan from Pescado Company, which contains Lactobacillus plantarum, a well-known probiotic strain. The probiotic is intended to improve gut microbiota balance, which may lead to improved nutritional status and health outcomes in hemodialysis patients. The dosage is one tablet daily for a duration of six months.

DIETARY_SUPPLEMENT

Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)

This intervention involves daily supplementation of Lactogemikan (containing Lactobacillus plantarum) combined with prebiotic fibers from oat (3g per day). The synbiotic is designed to provide the benefits of both probiotics (to balance gut microbiota) and prebiotics (to support the growth of beneficial bacteria). This intervention is intended to improve the nutritional status of hemodialysis patients over a 6-month period. The dosage is one tablet daily, combined with 3g of oat fiber.

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2025-10-15

Completion

2025-11-01