Effect of Gum Arabic on Gastrointestinal Transit and Permeability
NCT ID: NCT03742076
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
27 participants
INTERVENTIONAL
2018-12-18
2021-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Metabolic Response of Intestinal Microbiota to Guar Gum Consumption
NCT05195255
To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults
NCT04351841
Investigating the Impact of the Seaweed Derived Food Additive, Carrageenan, on the Human Gut Microbiome
NCT06738329
The Effect of Fruit/Vegetable Drinks on the Human Intestine
NCT02377063
Antibacterial Effect of Probiotic Yogurt Compared to Xylitol
NCT03889015
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-dose prebiotic
10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks
High-dose prebiotic
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
Low-dose prebiotic
5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks
Low-dose prebiotic
This is a spray-dried powder, yellowish-white in color, that is dissolvable.
Placebo
2 gm powdered fiber daily for at least 6 weeks
Placebo
Powder fiber supplement, yellowish-white in color, that is dissolvable.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-80
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Purna C. Kashyap, MBBS
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Purna C Kashyap, MBBS
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18-001008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.