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NCT Number: NCT07296146

Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

The goal of this clinical trial is to assess whether probiotic supplementation can improve the hematological response of CKD patients to erythropoietin therapy and prevent or reduce erythropoietin resistance. The main questions it aims to answer are:

Can probiotic be used as an adjuvant strategy in anemia management and increasing ESA responsiveness in CKD? What medical problems do participants have when taking probiotic? Researchers will compare Erythropoietin only with Erythropoietin + Probiotic to see if Probiotic aids in treating anaemic chronic kidney disease patients.

Participants will:

Take Erythropoietin + Probiotic or Probiotic only every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms

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Key information

Conditions

Anaemia Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Regular Hemodialysis Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with end stage renal disease for more than 3 months on regular hemodialysis (GFR less than 15 ml/min/m2
  • Receiving stable doses of erythropoietin therapy
  • Able and willing to provide informed consent

Exclusion criteria

  • Recent probiotic, antibiotic, or immunosuppressive therapy
  • Microcytic hypochromic anemia.
  • Patients with hyperparathyroidism
  • Recent or planned kidney transplantation Gastrointestinal disorders (active IBD, cancer)
  • Pregnancy or lactation
  • Severe comorbidities (e.g., active infection, malignancies)
  • Cognitive or physical inability to comply with protocol

Treatment and study plan

Erythropoietin + Probiotic

Drug

Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic

EPO

Drug

Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin

Primary outcomes

  1. - Hemoglobin concentration

    Time frame: at baseline, and 3-months postintervention

    • Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively

  2. - Erythropoietin resistance index (ERI)

    Time frame: at baseline, and 3-months postintervention

    • ERI = (ESA dose per week) / (body weight) / (hemoglobin level).

Secondary outcomes

  1. C-reactive protein

    Time frame: at baseline, and 3-months postintervention

    mg/dl

  2. serum urea

    Time frame: at baseline, and 3-months postintervention

    mg/dl

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Swan, PHD

CONTACT

[email protected]

+201090111013

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin in Chronic Kidney Disease Patients.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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