Impact of Gum Acacia on Chronic Kidney Disease Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Dietary supplement: Gum acacia

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Kidney and Urology Center (KUC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Merna M. AbouKhatwa, BSc, Faculty of Pharmacy, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): January 17, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 0107213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No