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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO + Probiotic | Active Comparator | EPO (4000 IU) + Probiotic (Lactobacillus acidophilus, 5 billion) |
|
| EPO | Active Comparator | Erythropoietin (Epoetin 4000 IU) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin + Probiotic | Drug | Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin + Probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| - Hemoglobin concentration | - Hemoglobin concentration (g/dL)at 2 weeks, and 3-months postoperatively | at baseline, and 3-months postintervention |
| - Erythropoietin resistance index (ERI) | - ERI = (ESA dose per week) / (body weight) / (hemoglobin level). | at baseline, and 3-months postintervention |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein | mg/dl | at baseline, and 3-months postintervention |
| serum urea | mg/dl | at baseline, and 3-months postintervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman Swan, PHD | Contact | +201090111013 | eman.said@buc.edu.eg |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| EPO | Drug | Anaemic chronic kidney disease patients on regular hemodialysis treated with Erythropoietin |
|
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |