Effect of Gum Arabic on Gastrointestinal Transit and Permeability

NCT03742076 | Completed

• 1 other identifier: 18-001008
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

• 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

  Change is being assessed between baseline and 6 weeks

Secondary Outcomes (1)

• Intestinal Permeability

  Change is being assessed between baseline and 6 weeks

Study Arms (3)

High-dose prebiotic

ACTIVE COMPARATOR

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

Dietary Supplement: High-dose prebiotic

Low-dose prebiotic

ACTIVE COMPARATOR

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

Dietary Supplement: Low-dose prebiotic

Placebo

PLACEBO COMPARATOR

2 gm powdered fiber daily for at least 6 weeks

Dietary Supplement: Placebo

Interventions

High-dose prebiotic DIETARY_SUPPLEMENT

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

Also known as: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

High-dose prebiotic

Low-dose prebiotic DIETARY_SUPPLEMENT

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

Also known as: Acacia, gum acacia, acacia gum, gum arabic, arabic gum

Low-dose prebiotic

Placebo DIETARY_SUPPLEMENT

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

Also known as: Dextrin fiber powder

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diverticulitis

Interventions

Prebiotics; Gum Arabic

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Officials

• Purna C Kashyap, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 15, 2018
• Study Start: December 18, 2018
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: July 10, 2023

Record last verified: 2023-07

Locations

US (1)