Kidney Failure, ChronicNCT03789708
Effects of Gum Arabic Supplementation in Hemodialysis Patients
A study testing Gum Arabic in people with Kidney Failure, Chronic, run by University of Khartoum at 1 site in Sudan.
Trial summary
Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Gum Arabic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSudan
- Study dates
- 1 Nov 2018to 1 Jun 2019
- 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
- Adult end-stage renal disease patients maintained on regular hemodialysis
Who cannot join
- Chronic liver disease
- Malignant condition
- Inflammatory bowel disease
- History of bowel resection
- Long term antibiotic therapy
- Pregnancy or lactation
- Current use of immunosuppressive medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Gum Arabic, Placebo
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDietary supplement
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
PlaceboOther
Maltodextrin powder, easily soluble
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients will receive 10 g of Gum Arabic supplementation daily for four weeks. Gum Arabic is provided in the form of easily soluble granules. Participants are asked to dissolve it in water or juice and drink it. Receives: Dietary Supplement: Gum Arabic |
| B | Placebo comparator | Patients will receive 5 g of maltodextrin supplementation daily for four weeks. Maltodextrin is an easily digested polysacharide provided in the form of soluble whitish powder that has no taste or odor. Participants are asked to dissolve it in water or juice and drink it. Receives: Other: Placebo |
| C | Experimental | Patients will receive 20 g of Gum Arabic supplementation daily for four weeks Receives: Dietary Supplement: Gum Arabic |
| D | Experimental | Patients will receive 40 g of Gum Arabic supplementation daily for four weeks Receives: Dietary Supplement: Gum Arabic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highly sensitive C-reactive protein (hs CRP) level
Change in serum level of highly sensitive C-reactive protein.
Measured: 4 weeks
Total anti-oxidant capacity
Change in serum total anti-oxidant capacity
Measured: 4 weeks
Blood urea level
Change in urea blood level
Measured: 4 weeks
Secondary outcomes (3)
Serum calcium
Change in serum calcium level
Measured: 4 weeks
Serum phosphorus
Change in serum phosphorus level
Measured: 4 weeks
Serum uric acid
Change in serum uric acid level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Nov 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- 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
- Randomized and controlled clinical trial with parallel design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Khartoum
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Kidney Diseases and Surgery, Almughtaribeen University
- Responsible party
- Principal investigator, Sarra Elamin, University of Khartoum
- Investigators
- Sarra Elamin, MD, Principal investigator, Consultant Nephrologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789708
- Sponsor's protocol ID
- 016227
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.
PubMed 37870148
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
- ClinicalTrials.gov ID
- NCT03789708
- Acronym / sponsor ID
- 016227
- Conditions
- Kidney Failure, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of KhartoumUniversity, hospital or other
- Collaborators
- National Center for Kidney Diseases and Surgery, Almughtaribeen University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 31 Dec 2018 (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.
Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
- Model description
- Randomized and controlled clinical trial with parallel design
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Gum ArabicPatients will receive 10 g of Gum Arabic supplementation daily for four weeks. Gum Arabic is provided in the form of easily soluble granules. Participants are asked to dissolve it in water or juice and drink it. |
| B | Placebo comparator | Other: PlaceboPatients will receive 5 g of maltodextrin supplementation daily for four weeks. Maltodextrin is an easily digested polysacharide provided in the form of soluble whitish powder that has no taste or odor. Participants are asked to dissolve it in water or juice and drink it. |
| C | Experimental | Dietary Supplement: Gum ArabicPatients will receive 20 g of Gum Arabic supplementation daily for four weeks |
| D | Experimental | Dietary Supplement: Gum ArabicPatients will receive 40 g of Gum Arabic supplementation daily for four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult end-stage renal disease patients maintained on regular hemodialysis
Key exclusion criteria (7 listed)
- Chronic liver disease
- Malignant condition
- Inflammatory bowel disease
- History of bowel resection
- Long term antibiotic therapy
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 ArabicInstantly soluble granules of Gum Arabic; 100% Acacia Senegal | Dietary supplement | A, C, D |
| PlaceboMaltodextrin powder, easily soluble | Other | B |
Primary outcome
Highly sensitive C-reactive protein (hs CRP) level
Time frame: 4 weeks
Change in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity
Time frame: 4 weeks
Change in serum total anti-oxidant capacity
Blood urea level
Time frame: 4 weeks
Change in urea blood level
3 secondary outcomes
Serum calcium
Time frame: 4 weeks
Serum phosphorus
Time frame: 4 weeks
Serum uric acid
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 37870148Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Sarra Elamin, MD principal investigator
Consultant Nephrologist
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 Arabic in people with Kidney Failure, Chronic, run by University of Khartoum at 1 site in Sudan.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jan 2019. 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 Sudan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Highly sensitive C-reactive protein (hs CRP) level (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03789708, which also lists 1 linked publication.
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 3 Jan 2019.