Anaemia, Chronic Kidney Disease, Regular Hemodialysis
Conditions
Keywords
Probiotic, erythropoietin, resistant anaemia, chronic kidney disease patients
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
Interventions
DRUGErythropoietin + Probiotic
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic
DRUGEPO
Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin
Sponsors
Badr University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| - Hemoglobin concentration | at baseline, and 3-months postintervention | \- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively |
| - Erythropoietin resistance index (ERI) | at baseline, and 3-months postintervention | \- ERI = (ESA dose per week) / (body weight) / (hemoglobin level). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | at baseline, and 3-months postintervention | mg/dl |
| serum urea | at baseline, and 3-months postintervention | mg/dl |
Contacts
Primary ContactEman Swan, PHD
Outcome results
None listed