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Not yet recruiting NCT07296146

Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

Phase III Interventional Anaemia Chronic Kidney Disease Regular Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythropoietin + Probiotic, EPO.
Who it may be relevant to
Registry conditions: Anaemia, Chronic Kidney Disease, Regular Hemodialysis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • - Hemoglobin concentration [Time frame: at baseline, and 3-months postintervention]
  • - Erythropoietin resistance index (ERI) [Time frame: at baseline, and 3-months postintervention]
Secondary outcome measures (2)
  • C-reactive protein [Time frame: at baseline, and 3-months postintervention]
  • serum urea [Time frame: at baseline, and 3-months postintervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07296146 · 121-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗