NCT03789708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

December 27, 2018

Last Update Submit

December 31, 2018

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (3)

  • Highly sensitive C-reactive protein (hs CRP) level

    Change in serum level of highly sensitive C-reactive protein.

    4 weeks

  • Total anti-oxidant capacity

    Change in serum total anti-oxidant capacity

    4 weeks

  • Blood urea level

    Change in urea blood level

    4 weeks

Secondary Outcomes (3)

  • Serum calcium

    4 weeks

  • Serum phosphorus

    4 weeks

  • Serum uric acid

    4 weeks

Study Arms (4)

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.

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.

Other: Placebo

C

EXPERIMENTAL

Patients will receive 20 g of Gum Arabic supplementation daily for four weeks

Dietary Supplement: Gum Arabic

D

EXPERIMENTAL

Patients will receive 40 g of Gum Arabic supplementation daily for four weeks

Dietary Supplement: Gum Arabic

Interventions

Gum ArabicDIETARY_SUPPLEMENT

Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

ACD
PlaceboOTHER

Maltodextrin powder, easily soluble

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doctor Salma Center for Kidney Diseases

Khartoum, 11111, Sudan

Location

Related Publications (1)

  • 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.

    PMID: 37870148DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Officials

  • Sarra Elamin, MD

    Consultant Nephrologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized and controlled clinical trial with parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 27, 2018

First Posted

December 31, 2018

Study Start

November 1, 2018

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

January 3, 2019

Record last verified: 2018-12

Locations

SU(1)