Impact of Gum Acacia on Chronic Kidney Disease Patients

NCT05599399 | Completed

• 1 other identifier: 0107213
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Effect of gum acacia on disease progression

  3 months

• Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system

  3 months

Study Arms (2)

Patients receiving gum acacia

ACTIVE COMPARATOR

Group one will receive gum acacia extract as an add-on therapy on daily basis

Dietary Supplement: Gum acacia

Patients receiving no intervention

NO INTERVENTION

Group two will not receive add-on therapy; they will receive standard care only.

Interventions

Gum acacia DIETARY_SUPPLEMENT

25 grams of gum acacia powder is administered on daily-basis

Patients receiving gum acacia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-hemodialysis CKD patients (Stage III -V)
• Age: above 18 years

You may not qualify if:

• Hemodialysis patients
• Pregnancy \& lactation
• Patients recently treated with antibiotic regimen (2 - 4 weeks)
• Malignancy
• Inflammatory bowel disease

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Kidney and Urology Center (KUC)

Alexandria, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Merna M. AbouKhatwa, BSc

  Faculty of Pharmacy, Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 31, 2022
• Study Start: July 18, 2022
• Primary Completion: January 17, 2023
• Study Completion: April 28, 2023
• Last Updated: June 22, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)