Effect of Gum Arabic on Gastrointestinal Transit and Permeability

July 7, 2023 updated by: Purna C. Kashyap, MBBS, Mayo Clinic
The study aims to determine the effect of gum arabic on gut bacteria and GI function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
  2. Known diagnosis of inflammatory bowel disease (Crohn's or ulcerative colitis), microscopic colitis, celiac disease, or other inflammatory condition other than diverticulitis
  3. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
  4. 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)
  5. Use of osmotic laxatives one week prior to Visit 2 and for the duration of the study
  6. Use of oral corticosteroids within the previous 6 weeks and for the duration of the study
  7. 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
  8. 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)
  9. 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
  10. Pregnancy or plan to become pregnant within the study timeframe
  11. Vulnerable adults
  12. Egg allergy or resistant to ingesting eggs
  13. Diagnosis of diabetes
  14. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-dose prebiotic
10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks
Dietary supplement: High-dose prebiotic
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
Other Names:
  • Acacia, gum acacia, acacia gum, gum arabic, arabic gum
Active Comparator: Low-dose prebiotic
5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks
Dietary supplement: Low-dose prebiotic
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 Comparator: Placebo
2 gm powdered fiber daily for at least 6 weeks
Dietary supplement: Placebo
Powder fiber supplement, yellowish-white in color, that is dissolvable.
Other Names:
  • Dextrin fiber powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change is being assessed between baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change is being assessed between baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Purna C Kashyap, MBBS, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2018

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 12, 2018

First Posted (Actual)

November 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-001008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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