Effect of Probiotic Supplementation on Resistant Anaemia to Erythropoietin in Chronic Kidney Disease Patients.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Primary Endpoint
- - Hemoglobin concentration
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
EPO + Probiotic
EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion)
Intervention: Erythropoietin + Probiotic (Drug)
EPO
Erythropoietin (Epoetin 4000 IU)
Intervention: EPO (Drug)
Outcomes
Primary Outcomes
- Hemoglobin concentration
Time Frame: at baseline, and 3-months postintervention
\- Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively
- Erythropoietin resistance index (ERI)
Time Frame: at baseline, and 3-months postintervention
\- ERI = (ESA dose per week) / (body weight) / (hemoglobin level).
Secondary Outcomes
- C-reactive protein(at baseline, and 3-months postintervention)
- serum urea(at baseline, and 3-months postintervention)
Investigators
Eman Said Sawan
Lecturer
Badr University