<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789708</url>
  </required_header>
  <id_info>
    <org_study_id>016227</org_study_id>
    <nct_id>NCT03789708</nct_id>
  </id_info>
  <brief_title>Effects of Gum Arabic Supplementation in Hemodialysis Patients</brief_title>
  <official_title>Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Khartoum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Kidney Diseases and Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Almughtaribeen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Khartoum</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex&#xD;
      polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria,&#xD;
      it's expected to reduce systemic levels of toxic bacterial metabolites and reduce&#xD;
      inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood&#xD;
      urea level. These changes are potentially beneficial to hemodialysis patients who suffer from&#xD;
      disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize&#xD;
      that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would&#xD;
      reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea&#xD;
      concentration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized and controlled clinical trial with parallel design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The placebo and the Gum Arabic are provided to patients in similar unlabeled packages</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Highly sensitive C-reactive protein (hs CRP) level</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum level of highly sensitive C-reactive protein.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total anti-oxidant capacity</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum total anti-oxidant capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood urea level</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in urea blood level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum calcium</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum calcium level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum phosphorus</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum phosphorus level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum uric acid</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in serum uric acid level</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 20 g of Gum Arabic supplementation daily for four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 40 g of Gum Arabic supplementation daily for four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gum Arabic</intervention_name>
    <description>Instantly soluble granules of Gum Arabic; 100% Acacia Senegal</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>C</arm_group_label>
    <arm_group_label>D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin powder, easily soluble</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult end-stage renal disease patients maintained on regular hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic liver disease&#xD;
&#xD;
          -  Malignant condition&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
&#xD;
          -  History of bowel resection&#xD;
&#xD;
          -  Long term antibiotic therapy&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Current use of immunosuppressive medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarra Elamin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant Nephrologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Doctor Salma Center for Kidney Diseases</name>
      <address>
        <city>Khartoum</city>
        <zip>11111</zip>
        <country>Sudan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sudan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Khartoum</investigator_affiliation>
    <investigator_full_name>Sarra Elamin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789708
org study id: 016227
nct id: NCT03789708
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized and controlled clinical trial with parallel design
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
measure: Highly sensitive C-reactive protein (hs CRP) level
time frame: 4 weeks
description: Change in serum level of highly sensitive C-reactive protein.
measure: Total anti-oxidant capacity
time frame: 4 weeks
description: Change in serum total anti-oxidant capacity
measure: Blood urea level
time frame: 4 weeks
description: Change in urea blood level
measure: Serum calcium
time frame: 4 weeks
description: Change in serum calcium level
measure: Serum phosphorus
time frame: 4 weeks
description: Change in serum phosphorus level
measure: Serum uric acid
time frame: 4 weeks
description: Change in serum uric acid level
arm group label: A
arm group type: Experimental
description: 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.
arm group label: B
arm group type: Placebo Comparator
description: 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.
arm group label: C
arm group type: Experimental
description: Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
arm group label: D
arm group type: Experimental
description: Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
intervention type: Dietary Supplement
intervention name: Gum Arabic
description: Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
arm group label: A
arm group label: C
arm group label: D
intervention type: Other
intervention name: Placebo
description: Maltodextrin powder, easily soluble
arm group label: B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarra Elamin, MD
role: Principal Investigator
affiliation: Consultant Nephrologist
facility: 
country: Sudan
responsible party type: Principal Investigator
investigator affiliation: University of Khartoum
investigator full name: Sarra Elamin
investigator title: Assistant Professor
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided