Back to results

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

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT05599399

First Posted

October 14, 2022

Last Updated

June 19, 2023

Sponsor

Alexandria University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Eligibility Criteria

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

Learn more about this trial

Impact of Gum Acacia on Chronic Kidney Disease Patients

We'll reach out to this number within 24 hrs