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Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.

NCT ID: NCT07296146

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-05-15

Brief Summary

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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

Detailed Description

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Conditions

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Anaemia Chronic Kidney Disease Regular Hemodialysis

Keywords

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Probiotic erythropoietin resistant anaemia chronic kidney disease patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EPO + Probiotic

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

Group Type ACTIVE_COMPARATOR

Erythropoietin + Probiotic

Intervention Type DRUG

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

EPO

Erythropoietin (Epoetin 4000 IU)

Group Type ACTIVE_COMPARATOR

EPO

Intervention Type DRUG

Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin

Interventions

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Erythropoietin + Probiotic

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

Intervention Type DRUG

EPO

Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Badr University

OTHER

Sponsor Role lead

Responsible Party

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Eman Said Sawan

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Eman Swan, PHD

Role: CONTACT

Phone: +201090111013

Email: [email protected]

Other Identifiers

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121-2025

Identifier Type: -

Identifier Source: org_study_id