Impact of Gum Acacia on Chronic Kidney Disease Patients

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Dietary Supplement: Gum acacia

• Registration Number: NCT05599399
• Lead Sponsor: Alexandria University

Brief Summary

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

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.

2. All participants should agree to take part in this clinical study and will provide informed consent.

3. 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.

4. All patients will be submitted to :

* Full patient history and clinical examination.

* Blood withdrawal in order to conduct lab work.

5. Patients demographic data will be recorded with respect to age, weight and other co-morbidities.

6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.

7. Results, conclusion, discussion and recommendations will be given.

Study Timeline

• Study Start: 2022-07-18
• Status Verified: 2022-09
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-10-31
• Primary Completion: 2023-01-17
• Study Completion: 2023-04-28
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients receiving gum acacia	Gum acacia	Group one will receive gum acacia extract as an add-on therapy on daily basis

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Effect of gum acacia on disease progression	3 months	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
Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system	3 months	Patients will be contacted on a regular basis to monitor adverse effects

Trial Locations

Locations (1)

Kidney and Urology Center (KUC); 🇪🇬 Alexandria, Egypt