Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

NCT07296146 — Phase 3, Not yet recruiting, 80 participants, Badr University

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

Registry	NCT07296146
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	Badr University (Other)
Conditions	Anaemia, Chronic Kidney Disease, Regular Hemodialysis
Interventions	Erythropoietin + Probiotic, EPO (Drug)
Dates	start 2025-12-15 (estimated), primary completion 2026-03-15 (estimated), completion 2026-05-15 (estimated), first posted 2025-12-22, last updated 2025-12-22

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
EPO + Probiotic	Active comparator	Drug: Erythropoietin + Probiotic	EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion)
EPO	Active comparator	Drug: EPO	Erythropoietin (Epoetin 4000 IU)

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

+Outcome measures

Primary outcomes

- Hemoglobin concentration [at baseline, and 3-months postintervention]: \- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively
- Erythropoietin resistance index (ERI) [at baseline, and 3-months postintervention]: \- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).

Secondary outcomes

C-reactive protein [at baseline, and 3-months postintervention]: mg/dl
serum urea [at baseline, and 3-months postintervention]: mg/dl

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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