Effect of Gum Arabic on Gastrointestinal Transit and Permeability

Diverticulitis Clinical Trial

Official title:

Effect of Gum Arabic on Gastrointestinal Transit and Permeability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742076
• Other study ID #: 18-001008
• Status: Completed
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Dietary Supplement:
• High-dose prebiotic
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
• Low-dose prebiotic
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
• Placebo
Powder fiber supplement, yellowish-white in color, that is dissolvable.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Change is being assessed between baseline and 6 weeks

External Links

•   Mayo Clinic Clinical Trials