Effects of Gum Arabic Supplementation in Hemodialysis Patients

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03789708
• Other study ID #: 016227
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: December 2018
• Source: University of Khartoum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Dietary Supplement:
• Gum Arabic
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

Other:
• Placebo
Maltodextrin powder, easily soluble

Locations

Country	Name	City	State
Sudan	Doctor Salma Center for Kidney Diseases	Khartoum

Sponsors (3)

Lead Sponsor	Collaborator
University of Khartoum	Almughtaribeen University, National Center for Kidney Diseases and Surgery

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highly sensitive C-reactive protein (hs CRP) level	Change in serum level of highly sensitive C-reactive protein.	4 weeks
Primary	Total anti-oxidant capacity	Change in serum total anti-oxidant capacity	4 weeks
Primary	Blood urea level	Change in urea blood level	4 weeks
Secondary	Serum calcium	Change in serum calcium level	4 weeks
Secondary	Serum phosphorus	Change in serum phosphorus level	4 weeks
Secondary	Serum uric acid	Change in serum uric acid level	4 weeks