Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMansoura University
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Lactogemikan (Probiotic Supplement)
Dietary supplementThis 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.
Lactogemikan + Prebiotic Fiber (Synbiotic Supplement)
Dietary supplementThis 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Control Group (No Intervention)No intervention 0 interventions
Group B: Probiotic GroupExperimental treatment 1 intervention
Group C: Synbiotic GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Body Mass Index (BMI) after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients
The primary outcome measure will assess the change in Body Mass Index (BMI) as a marker of nutritional status in hemodialysis patients who receive probiotic or synbiotic supplementation. BMI will be measured using standard weight and height measurements at baseline (before supplementation) and at 6 months. A change in BMI will be used to evaluate the overall effect of these interventions on the patients' nutritional status.
Time frame
BMI will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).Secondary outcomes
1
Change from Baseline in Serum RAGE Levels after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients
The secondary outcome measure will assess the change in serum RAGE (Receptor for Advanced Glycation End-products) levels as a marker of oxidative stress and inflammation in hemodialysis patients who receive probiotic or synbiotic supplementation. Serum samples will be collected at baseline (before supplementation) and at 6 months to measure RAGE levels. Changes in RAGE levels will be used to assess the impact of the interventions on oxidative stress and inflammatory markers in these patients. RAGE: Elevated levels of RAGE are associated with increased oxidative stress and inflammation, which are common complications in patients with ESRD undergoing hemodialysis.
Time frame
Serum RAGE levels will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).2
Change from Baseline in Serum Leptin Levels after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients
This secondary outcome will assess the change in serum leptin levels as a marker of adiposity and metabolic health in hemodialysis patients receiving probiotic or synbiotic supplementation. Serum samples will be collected at baseline (before supplementation) and at 6 months to measure leptin levels. Changes in leptin levels will help determine the impact of the interventions on nutritional status and metabolic dysfunction in these patients. Leptin: Leptin is a hormone produced by adipose tissue, and its levels are typically associated with body fat mass and energy balance.
Time frame
Serum leptin levels will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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