Chronic Kidney DiseasesNCT05599399
Impact of Gum Acacia on Chronic Kidney Disease Patients
A study testing Gum acacia in people with Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Gum acacia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jul 2022to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-hemodialysis CKD patients (Stage III -V)
- Age: above 18 years
Who cannot join
- Hemodialysis patients
- Pregnancy \& lactation
- Patients recently treated with antibiotic regimen (2 - 4 weeks)
- Malignancy
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Gum Acacia on Gut-microbiota Derived Metabolites in 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Gum acacia
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum acaciaDietary supplement
25 grams of gum acacia powder is administered on daily-basis
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving gum acacia | Active comparator | Group one will receive gum acacia extract as an add-on therapy on daily basis Receives: Dietary Supplement: Gum acacia |
| Patients receiving no intervention | No intervention | Group two will not receive add-on therapy; they will receive standard care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins
indoxyl sulfate, p-cresyl sulfate sulfate)
Measured: 3 months
Mean change from baseline values of complete blood picture
Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT)
Measured: 3 months
Mean change from baseline values of serum electrolytes levels
Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus
Measured: 3 months
Mean change from baseline values of serum albumin levels
Suggested parameters include: serum albumin
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start18 Jul 2022
- Primary completion17 Jan 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Merna M. AbouKhatwa, BSc, Principal investigator, Faculty of Pharmacy, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599399
- Sponsor's protocol ID
- 0107213
- Status last verified
- Sep 2022
- First submitted
- 14 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gum Acacia on Gut-microbiota Derived Metabolites in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT05599399
- Acronym / sponsor ID
- 0107213
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patients receiving gum acacia | Active comparator | Dietary Supplement: Gum acaciaGroup one will receive gum acacia extract as an add-on therapy on daily basis |
| Patients receiving no intervention | No intervention | –Group two will not receive add-on therapy; they will receive standard care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non-hemodialysis CKD patients (Stage III -V)
- Age: above 18 years
Key exclusion criteria (5 listed)
- Hemodialysis patients
- Pregnancy \& lactation
- Patients recently treated with antibiotic regimen (2 - 4 weeks)
- Malignancy
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum acacia25 grams of gum acacia powder is administered on daily-basis | Dietary supplement | Patients receiving gum acacia |
Primary outcome
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)
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)
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)
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
Mean change from baseline values of serum albumin levels
Time frame: 3 months
Suggested parameters include: serum albumin
2 secondary outcomes
Effect of gum acacia on disease progression
Time frame: 3 months
Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merna M. AbouKhatwa, BSc principal investigator
Faculty of Pharmacy, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum acacia in people with Chronic Kidney Diseases, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline values of renal profile of chronic kidney disease patients. (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.