Probiotics Against Erythropoietin Resistance in Chronic Kidney Disease Patients.
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBadr University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Recent probiotic, antibiotic, or immunosuppressive therapy
Microcytic hypochromic anemia.
Patients with hyperparathyroidism
Recent or planned kidney transplantation Gastrointestinal disorders (active IBD, cancer)
Trial design
Design model
Parallel
Treatments tested in this trial
Erythropoietin + Probiotic
DrugAnaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic
EPO
DrugAnaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: EPO + ProbioticActive comparator 1 intervention
Group B: EPOActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
- Hemoglobin concentration
\- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively
Time frame
at baseline, and 3-months postintervention2
- Erythropoietin resistance index (ERI)
\- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).
Time frame
at baseline, and 3-months postinterventionSecondary outcomes
1
C-reactive protein
mg/dl
Time frame
at baseline, and 3-months postintervention2
serum urea
mg/dl
Time frame
at baseline, and 3-months postinterventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: