Impact of Gum Acacia on Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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The aim of the study is to evaluate the impact of gum acacia on serum levels of protein-bound uremic toxins (indoxyl sulfate and p-cresyl sulfate).In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.

Detailed Description
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Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. All participants should agree to take part in this clinical study and will provide informed consent. Eighty chronic kidney disease patients,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 80 participants will be randomly assigned into 2 arms. Control arm (n=40): will be treated with standard treatment without any herbal intervention. Intervention arm (n=40): will be treated with standard treatment in addition to gum acacia sachets. Each sachet contains 25 g of gum acacia powder to be taken on daily-basis for 3 months. All patients will be submitted to : Full patient history and clinical examination. Blood withdrawal in order to conduct lab work. Patients demographic data will be recorded with respect to age, weight and other co-morbidities. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion and recommendations will be given.

Official Title
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Impact of Gum Acacia on Gut-microbiota Derived Metabolites in Chronic Kidney Disease Patients

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Dietary Supplement: Gum acacia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-hemodialysis CKD patients (Stage III -V) Age: above 18 years Exclusion Criteria: Hemodialysis patients Pregnancy & lactation Patients recently treated with antibiotic regimen (2 - 4 weeks) Malignancy Inflammatory bowel disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients receiving gum acacia<br>Group one will receive gum acacia extract as an add-on therapy on daily basis | Dietary Supplement: Gum acacia<br>* 25 grams of gum acacia powder is administered on daily-basis<br>|
| No Intervention: Patients receiving no intervention<br>Group two will not receive add-on therapy; they will receive standard care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline values of renal profile of chronic kidney disease patients. | Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR) | 3 months | 
| Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins | indoxyl sulfate, p-cresyl sulfate sulfate) | 3 months | 
| Mean change from baseline values of complete blood picture | Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT) | 3 months | 
| Mean change from baseline values of serum electrolytes levels | Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus | 3 months | 
| Mean change from baseline values of serum albumin levels | Suggested parameters include: serum albumin | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of gum acacia on disease progression | expressed in terms of loss 50% in glomerular filtration rate and need for renal replacement therapy loss 50% in glomerular filtration rate and need for renal replacement therapy | 3 months | 
| Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system | Patients will be contacted on a regular basis to monitor adverse effects | 3 months |