An interventional study of Gum Arabic and Placebo in Kidney Failure, Chronic, sponsored by University of Khartoum. Status unknown at 1 site in Sudan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by University of Khartoum · Not applicable, Interventional, and Treatment
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 80 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →University of Khartoum is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Gum Arabic
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.
Other: Placebo
Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
Dietary Supplement: Gum Arabic
Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
Dietary Supplement: Gum Arabic
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
Maltodextrin powder, easily soluble
Highly sensitive C-reactive protein (hs CRP) level
Change in serum level of highly sensitive C-reactive protein.
Time frame: 4 weeks
Total anti-oxidant capacity
Change in serum total anti-oxidant capacity
Time frame: 4 weeks
Blood urea level
Change in urea blood level
Time frame: 4 weeks
Serum calcium
Change in serum calcium level
Time frame: 4 weeks
Serum phosphorus
Change in serum phosphorus level
Time frame: 4 weeks
Serum uric acid
Change in serum uric acid level
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2018 (actual). Primary completion is estimated for Mar 2019, 4 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 4 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gum Arabic
University of Khartoum