Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

Badr University

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Kidney Disease; Regular Hemodialysis; Anaemia

Treatments: Drug: EPO; Drug: Erythropoietin + Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT07296146

121-2025

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

EPO + Probiotic

Active Comparator group

Description:

EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion)

Treatment:

Drug: Erythropoietin + Probiotic

EPO

Active Comparator group

Description:

Erythropoietin (Epoetin 4000 IU)

Treatment:

Drug: EPO