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Effect of Gum Arabic on Gastrointestinal Transit and Permeability

Primary Purpose

Diverticulitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

High-dose prebiotic

Low-dose prebiotic

Placebo

About this trial

This is an interventional other trial for Diverticulitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

High-dose prebiotic

Low-dose prebiotic

Placebo

Arm Description

10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

2 gm powdered fiber daily for at least 6 weeks

Outcomes

Primary Outcome Measures

Colonic Transit time

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 Outcome Measures

Intestinal Permeability

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.

Full Information

NCT ID

NCT03742076

First Posted

November 5, 2018

Last Updated

July 7, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03742076

Brief Title

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

Official Title

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

December 18, 2018 (Actual)

Primary Completion Date

March 1, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diverticulitis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose prebiotic

Arm Type

Active Comparator

Arm Description

10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

Arm Title

Low-dose prebiotic

Arm Type

Active Comparator

Arm Description

5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

2 gm powdered fiber daily for at least 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

High-dose prebiotic

Other Intervention Name(s)

Acacia, gum acacia, acacia gum, gum arabic, arabic gum

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Low-dose prebiotic

Other Intervention Name(s)

Acacia, gum acacia, acacia gum, gum arabic, arabic gum

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Dextrin fiber powder

Intervention Description

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

Primary Outcome Measure Information:

Title

Colonic Transit time

Description

Time Frame

Change is being assessed between baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Intestinal Permeability

Description

Time Frame

Change is being assessed between baseline and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Purna C Kashyap, MBBS

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

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