NCT06891105Not yet recruiting
Effect of Probiotic and Synbiotic Administration on Nutritional Status in Hemodialysis Patients
Effect of Probiotic and Synbiotic Administration on the Nutritional Status of Hemodialysis Patients. a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 18 Mar 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 15 Oct 2025
- Lead sponsor
- Mansoura University
- Diseases
- Chronic kidney disease
- NCT number
- NCT06891105
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Apr 2025 to the primary completion date, 15 Oct 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are actively preparing for kidney transplantation.
Other illness
- 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.
Other
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Related publications
- Effect of probiotic and synbiotic administration on the nutritional status of hemodialysis patients: a randomized-controlled trial.Int Urol Nephrol · 2026 · PMID 41872650
This page is information, not medical advice. Discuss any trial with your doctor.