Impact of Gum Acacia on Chronic Kidney Disease Patients
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Gum acacia
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
Eligibility Criteria
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
Sites / Locations
- Kidney and Urology Center (KUC)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patients receiving gum acacia
Patients receiving no intervention
Arm Description
Group one will receive gum acacia extract as an add-on therapy on daily basis
Group two will not receive add-on therapy; they will receive standard care only.
Outcomes
Primary Outcome Measures
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)
Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins
indoxyl sulfate, p-cresyl sulfate sulfate)
Mean change from baseline values of complete blood picture
Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)
Mean change from baseline values of serum electrolytes levels
Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus
Mean change from baseline values of serum albumin levels
Suggested parameters include: serum albumin
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05599399
Brief Title
Impact of Gum Acacia on Chronic Kidney Disease Patients
Official Title
Impact of Gum Acacia on Gut-microbiota Derived Metabolites in Chronic Kidney Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving gum acacia
Arm Type
Active Comparator
Arm Description
Group one will receive gum acacia extract as an add-on therapy on daily basis
Arm Title
Patients receiving no intervention
Arm Type
No Intervention
Arm Description
Group two will not receive add-on therapy; they will receive standard care only.
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum acacia
Intervention Description
25 grams of gum acacia powder is administered on daily-basis
Primary Outcome Measure Information:
Title
Mean change from baseline values of renal profile of chronic kidney disease patients.
Description
Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR)
Time Frame
3 months
Title
Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins
Description
indoxyl sulfate, p-cresyl sulfate sulfate)
Time Frame
3 months
Title
Mean change from baseline values of complete blood picture
Description
Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)
Time Frame
3 months
Title
Mean change from baseline values of serum electrolytes levels
Description
Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus
Time Frame
3 months
Title
Mean change from baseline values of serum albumin levels
Description
Suggested parameters include: serum albumin
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Effect of gum acacia on disease progression
Description
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
Time Frame
3 months
Title
Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system
Description
Patients will be contacted on a regular basis to monitor adverse effects
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merna M. AbouKhatwa, BSc
Organizational Affiliation
Faculty of Pharmacy, Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kidney and Urology Center (KUC)
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Gum Acacia on Chronic Kidney Disease Patients
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