Impact of Gum Acacia on Chronic Kidney Disease Patients

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05599399
• Other study ID #: 0107213
• Status: Completed
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: April 28, 2023

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 28, 2023
• Est. primary completion date: January 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Gum acacia
25 grams of gum acacia powder is administered on daily-basis

Locations

Country	Name	City	State
Egypt	Kidney and Urology Center (KUC)	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins	indoxyl sulfate, p-cresyl sulfate sulfate)	3 months
Primary	Mean change from baseline values of complete blood picture	Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)	3 months
Primary	Mean change from baseline values of serum electrolytes levels	Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus	3 months
Primary	Mean change from baseline values of serum albumin levels	Suggested parameters include: serum albumin	3 months
Secondary	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
Secondary	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