Clinical trial NCT05599399: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change from baseline values of renal profile of chronic kidney disease patients.
timeFrame: 3 months
measure: Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins
timeFrame: 3 months
measure: Mean change from baseline values of complete blood picture
timeFrame: 3 months
measure: Mean change from baseline values of serum electrolytes levels
timeFrame: 3 months
measure: Mean change from baseline values of serum albumin levels
timeFrame: 3 months
Secondary outcomes:
measure: Effect of gum acacia on disease progression
timeFrame: 3 months
measure: Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Kidney and Urology Center (KUC)
Study officials:
affiliation: Faculty of Pharmacy, Alexandria University
name: Merna M. AbouKhatwa, BSc
role: PRINCIPAL_INVESTIGATOR
References: