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The study aims to determine the effect of gum arabic on gut bacteria and GI function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose prebiotic | Active Comparator | 10 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks |
|
| Low-dose prebiotic | Active Comparator | 5 gm gum arabic (powder) with 2 gm fiber powder daily for at least 6 weeks |
|
| Placebo | Placebo Comparator | 2 gm powdered fiber daily for at least 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose prebiotic | Dietary Supplement | This is a spray-dried powder, yellowish-white in color, that is dissolvable. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Purna C Kashyap, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D006170 | Gum Arabic |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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| Low-dose prebiotic | Dietary Supplement | This is a spray-dried powder, yellowish-white in color, that is dissolvable. |
|
|
| Placebo | Dietary Supplement | Powder fiber supplement, yellowish-white in color, that is dissolvable. |
|
|
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |