Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

December 8, 2025 updated by: Eman Said Sawan, Badr University

Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EPO + Probiotic
EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion)
Drug: Erythropoietin + Probiotic
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic
Active Comparator: EPO
Erythropoietin (Epoetin 4000 IU)
Drug: EPO
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein
Time Frame: at baseline, and 3-months postintervention
mg/dl
at baseline, and 3-months postintervention
serum urea
Time Frame: at baseline, and 3-months postintervention
mg/dl
at baseline, and 3-months postintervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 8, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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