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Completed

NCT Number: NCT05599399

Impact of Gum Acacia on 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kidney and Urology Center (KUC)

Alexandria, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gum acacia

Dietary Supplement

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

Primary outcomes

  1. Mean change from baseline values of renal profile of chronic kidney disease patients.

    Time frame: 3 months

    Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR)

  2. Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins

    Time frame: 3 months

    indoxyl sulfate, p-cresyl sulfate sulfate)

  3. Mean change from baseline values of complete blood picture

    Time frame: 3 months

    Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)

  4. Mean change from baseline values of serum electrolytes levels

    Time frame: 3 months

    Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus

  5. Mean change from baseline values of serum albumin levels

    Time frame: 3 months

    Suggested parameters include: serum albumin

Secondary outcomes

  1. Effect of gum acacia on disease progression

    Time frame: 3 months

    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

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

    Time frame: 3 months

    Patients will be contacted on a regular basis to monitor adverse effects

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2022
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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