Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

NCT07296146 | Not Yet Recruiting Phase 3

• 1 other identifier: 121-2025
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Anaemia; Chronic Kidney Disease; Regular Hemodialysis

Keywords

Probiotic; erythropoietin; resistant anaemia; chronic kidney disease patients

Outcome Measures

Primary Outcomes (2)

• - Hemoglobin concentration

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

  at baseline, and 3-months postintervention

• - Erythropoietin resistance index (ERI)

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

  at baseline, and 3-months postintervention

Secondary Outcomes (2)

• C-reactive protein

  at baseline, and 3-months postintervention

• serum urea

  at baseline, and 3-months postintervention

Study Arms (2)

EPO + Probiotic

ACTIVE COMPARATOR

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

Drug: Erythropoietin + Probiotic

EPO

ACTIVE COMPARATOR

Erythropoietin (Epoetin 4000 IU)

Drug: EPO

Interventions

Erythropoietin + Probiotic DRUG

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

EPO + Probiotic

EPO DRUG

Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin

EPO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Badr University: lead

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Erythropoietin; Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Eman Swan, PHD

CONTACT

+201090111013; eman.said@buc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 22, 2025
• Study Start: December 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share