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Search / Trial NCT06891105

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

Launched by MANSOURA UNIVERSITY · Mar 18, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

End Stage Renal Disease Hemodialysis Probiotics Synbiotics Nutritional Status Gut Microbiota

ClinConnect Summary

This clinical trial is exploring how probiotics and synbiotics can help improve the nutritional health of patients with end-stage kidney disease (ESRD) who are receiving hemodialysis. Patients with ESRD often struggle with nutrition and may have an imbalance in the healthy bacteria that live in their gut. The study will include 60 patients from a hemodialysis center in Mansoura, Egypt. Participants will be divided into three groups: one will receive probiotics (helpful bacteria), another will get synbiotics (a mix of probiotics and substances that feed good bacteria), and the third group will not receive any treatment. The researchers will check various health measurements, including body weight and protein levels, before and after six months to see if these supplements make a difference.

To be eligible for this trial, participants must be at least 18 years old, be on regular hemodialysis, and not be preparing for a kidney transplant. Those who are pregnant, have certain severe health conditions, or are allergic to probiotics or synbiotics cannot participate. The study aims to find new, affordable ways to improve the health of patients on long-term dialysis by understanding if these supplements can enhance their nutritional status.

Gender

ALL

Eligibility criteria

  • 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.

About Mansoura University

Mansoura University is a prestigious academic institution located in Egypt, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, it leverages its extensive resources and expertise in various fields of healthcare to facilitate innovative research initiatives aimed at improving patient outcomes. The university collaborates with a network of healthcare professionals and researchers to conduct high-quality clinical trials, focusing on addressing critical health challenges through rigorous scientific methodologies. Its dedication to ethical research practices and adherence to regulatory standards underscores its role as a leader in the medical research community.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported