Effect of Probiotic and Synbiotic Administration on the Nutritional Status of Hemodialysis Patients. a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mansoura University
- Enrollment
- 60
- Primary Endpoint
- Change from Baseline in Body Mass Index (BMI) after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients
Study Overview
Brief 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.
Detailed Description
This randomized controlled trial is designed to assess the effects of probiotic and synbiotic supplementation on the nutritional status of patients with end-stage kidney disease (ESRD) undergoing hemodialysis. Patients with ESRD face significant health challenges, including malnutrition, inflammation, and gut dysbiosis (an imbalance in gut bacteria), which contribute to poor health outcomes and reduced quality of life. These complications are exacerbated by the impact of the hemodialysis process, medications, and dietary restrictions commonly imposed on patients.
Probiotics are live microorganisms that provide health benefits when consumed in adequate amounts. In contrast, synbiotics combine probiotics with prebiotics, which are compounds that selectively stimulate the growth and activity of beneficial gut bacteria. The hypothesis of this study is that both probiotics and synbiotics will improve the nutritional status of hemodialysis patients by enhancing gut microbiota balance, reducing inflammation, and supporting better nutrient absorption.
Study Design: This study will be conducted at the Urology and Nephrology Center in Mansoura, Egypt. A total of 60 patients on regular hemodialysis will be randomly assigned to one of three groups:
Control group (20 patients) - No intervention. Probiotic group (20 patients) - Receives daily probiotic supplementation (Lactogemikan from Pescado Company).
Synbiotic group (20 patients) - Receives daily synbiotic supplementation (Lactogemikan plus prebiotic fiber from oats).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
- •Patients who have severe infections or other severe conditions that might interfere with the study's assessments.
- •Patients with known allergies to probiotics or synbiotics.
Arms & Interventions
Control Group (No Intervention)
This arm will include 20 participants who will not receive any treatment. The purpose of this group is to serve as a baseline for comparison with the two intervention arms. Participants will undergo regular hemodialysis treatment, but no probiotic or synbiotic supplementation will be provided.
Probiotic Group
This arm will consist of 20 participants who will receive daily probiotic supplementation (Lactogemikan from Pescado Company, containing Lactobacillus plantarum). The objective is to evaluate the effect of probiotics on the nutritional status, including BMI, skin fold thickness, and protein metabolism in hemodialysis patients. Participants will receive the probiotic for a duration of 6 months.
Intervention: Lactogemikan (Probiotic Supplement) (Dietary Supplement)
Synbiotic Group
This arm will include 20 participants who will receive daily synbiotic supplementation, which includes both probiotics (Lactogemikan from Pescado Company) and prebiotic fiber (oat, 3g/day). The purpose of this arm is to assess the impact of synbiotics on the nutritional status and gut microbiota balance of hemodialysis patients. Participants will receive the synbiotic for 6 months.
Intervention: Lactogemikan + Prebiotic Fiber (Synbiotic Supplement) (Dietary Supplement)
Outcomes
Primary Outcomes
Change from Baseline in Body Mass Index (BMI) after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients
Time Frame: BMI will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).
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.
Secondary Outcomes
- Change from Baseline in Serum RAGE Levels after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients(Serum RAGE levels will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).)
- Change from Baseline in Serum Leptin Levels after 6 Months of Probiotic and Synbiotic Supplementation in Hemodialysis Patients(Serum leptin levels will be assessed at baseline (before intervention) and at 6 months (after completing the 6-month supplementation period).)
Investigators
Walaa Mamdouh Mohamed Mahmoud
Principal Investigator
Mansoura University