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Effects of Gum Arabic Supplementation in Hemodialysis Patients

Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03789708
Enrollment
80
Registered
2018-12-31
Start date
2018-11-01
Completion date
2019-06-01
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTGum Arabic

Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

OTHERPlacebo

Maltodextrin powder, easily soluble

Sponsors

National Center for Kidney Diseases and Surgery
CollaboratorUNKNOWN
Almughtaribeen University
CollaboratorUNKNOWN
University of Khartoum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

The placebo and the Gum Arabic are provided to patients in similar unlabeled packages

Intervention model description

Randomized and controlled clinical trial with parallel design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult end-stage renal disease patients maintained on regular hemodialysis

Exclusion criteria

* Chronic liver disease * Malignant condition * Inflammatory bowel disease * History of bowel resection * Long term antibiotic therapy * Pregnancy or lactation * Current use of immunosuppressive medication

Design outcomes

Primary

MeasureTime frameDescription
Highly sensitive C-reactive protein (hs CRP) level4 weeksChange in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity4 weeksChange in serum total anti-oxidant capacity
Blood urea level4 weeksChange in urea blood level

Secondary

MeasureTime frameDescription
Serum calcium4 weeksChange in serum calcium level
Serum phosphorus4 weeksChange in serum phosphorus level
Serum uric acid4 weeksChange in serum uric acid level

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026