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Completed

NCT Number: NCT03742076

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

The study aims to determine the effect of gum arabic on gut bacteria and GI function.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut microbiota composition and function, GI transit and permeability, and assess development of symptoms or a change in pre-existing symptoms present, in patients with recent history of clinically diagnosed diverticulitis which has been successfully treated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent diagnosis of diverticulitis (within 24 months) and at least 4 weeks post antibiotic use
  • Age 18-80

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 visit 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 2 after a 4-week washout period)
  • Bowel preparation for colonoscopy less than one week prior to the 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

Treatment and study plan

High-dose prebiotic

Dietary Supplement

This is a spray-dried powder, yellowish-white in color, that is dissolvable.

Other names: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

Low-dose prebiotic

Dietary Supplement

This is a spray-dried powder, yellowish-white in color, that is dissolvable.

Other names: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

Placebo

Dietary Supplement

Powder fiber supplement, yellowish-white in color, that is dissolvable.

Other names: Dextrin fiber powder

Primary outcomes

  1. Colonic Transit time

    Time frame: Change is being assessed between baseline and 6 weeks

    The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. Units: units on a scale

Secondary outcomes

  1. Intestinal Permeability

    Time frame: Change is being assessed between baseline and 6 weeks

    To determine intestinal permeability, urine will be collected for 24 hours after drinking a sugar solution. The 0- to 2-hour urine most closely reflects small intestinal permeability and the 8- to 24-hour urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2018
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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