Effect of Gum Arabic on Gastrointestinal Transit and Permeability
Keywords
Coimriú
Cur síos
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.
Dátaí
| Fíoraithe Deireanach: | 02/29/2020 |
| Cuireadh isteach den chéad uair: | 11/04/2018 |
| Clárú Measta Curtha isteach: | 11/11/2018 |
| Arna chur suas ar dtús: | 11/14/2018 |
| Nuashonrú Deireanach Curtha isteach: | 03/10/2020 |
| Nuashonrú Deireanach Postáilte: | 03/12/2020 |
| Dáta Tosaigh an Staidéir Iarbhír: | 06/21/2018 |
| Dáta Críochnaithe Bunscoile Measta: | 12/30/2020 |
| Dáta Críochnaithe an Staid Mheasta: | 07/14/2021 |
Coinníoll nó galar
Idirghabháil / cóireáil
Dietary Supplement: High-dose prebiotic
Dietary Supplement: Low-dose prebiotic
Dietary Supplement: Placebo
Céim
Grúpaí Láimhe
| Lámh | Idirghabháil / cóireáil |
|---|---|
| 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. |
| 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. |
| 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. |
Critéir Incháilitheachta
| Aois Incháilithe le haghaidh Staidéir | 18 Years Chun 18 Years |
| Gnéas Incháilithe le haghaidh Staidéir | All |
| Glacann Oibrithe Deonacha Sláintiúla | Sea |
| Critéir | 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 |
Toradh
Bearta Toraidh Príomhúla
1. Colonic Transit time [Change is being assessed between baseline and 6 weeks]
Bearta Torthaí Tánaisteacha
1. Intestinal Permeability [Change is being assessed between baseline and 6 weeks]
