A Study to Assess the Effects of Gum Arabic on Gastrointestinal Transit and Permeability

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-001008
    NCT ID: NCT03742076
    Sponsor Protocol Number: 18-001008

About this study

This study is being done to determine if a low-dose or high-dose prebiotic along with a high-fiber diet improves symptoms of diverticulitis and gut function

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Patient Inclusion Criteria:

  • Recent diagnosis of diverticulitis (within 12 months).
  • Age 18-80 years old.

Patient Exclusion Criteria:

  • Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy).
  • Known diagnosis of inflammatory bowel disease (Crohn’s or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis.
  • Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability).
  • Use of NSAIDs or aspirin within the week prior to Visit 2 and Visit 5 (permeability and transit testing visits since NSAIDs affect intestinal permeability).
  • Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study.
  • Use of oral corticosteroids within the previous 6 weeks and for the duration of the study.
  • Ingestion of artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages.
  • Antibiotic use within 4 weeks of completion of the initial stool kit and/or Visit 2 testing appointment and for the remainder of the study (they can complete the stool kit and Visit 2after a four-week washout period).
  • Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and Visit 2 and during the remainder of the study.
  • Pregnancy or plan to become pregnant within the study timeframe.
  • Vulnerable adults.
  • Egg allergy or resistant to ingesting eggs.
  • Diagnosis of diabetes.
  • Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Purna Kashyap, M.B.B.S.

Open for enrollment

Contact information:

Heather Lekatz

(507)538-1206

Lekatz.Heather@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20432322

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