NCT01210625

Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

A Randomized, Double Blind, Controlled, Dose Ranging Trial to Compare Nutrabiotix Fiber to Psyllium Fiber in Patients Experiencing Constipation.

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that daily oral intake of starch-entrapped alginate microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal "typical" side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents; and promote gut health by improving bowel habit, by changing the gut microbiota and increasing production of short chain fatty acids, especially butyrate, in the colon and decreasing production of protein putrification (prebiotic effects).

Detailed description

The long-term objective of our research program is to show that targeted colonic delivery of natural specific fermentable carbohydrates will maintain and promote gut health by changing the gut microbiota \[prebiotic effect\], by increasing "protective and growth promoting" factors such as butyrate, and enhancing intestinal barrier function. These health-promoting functions may prevent and treat a wide range of disorders associated with an abnormal microbiota (dysbiosis) and/or disrupted gut barrier function. Examples of disorders associated with dysbiosis and disrupted gut barrier (leaky gut) are allergic disorders, inflammatory bowel disease, diverticular disease, colon polyps and cancer, alcoholic liver disease, non-alcoholic steatohepatitis (NASH- the most common liver disease in the USA), and irritable bowel syndrome (IBS, the most common GI illness in the US with a high loss of productivity and a high rate of utilization of health care resources). Nutrabiotix fiber is a prebiotic and is able to promote gut health through changes in the stool microbiota composition favoring saccharolytic bacteria like Bifidobacteria and diminishing proteolytic bacteria like Clostridia. This change in the intestinal microbiota composition should result in increases in the products of carbohydrate fermentation \[SCFA\] and decreases in the products of protein breakdown \[indoles and phenols\] in the stool. Also, the fiber is well tolerated and without side effects and is an effective fiber that increases stool bulk and regulates bowel movement.

Conditions

• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutrabiotix	Fiber supplement: 9mg or 12mg
DIETARY_SUPPLEMENT	Psyllium	12g total per day (4 capsules containing 1 gram psyllium fiber 3 times a day)

Timeline

• First posted: 2010-09-28
• Last updated: 2023-06-08

Locations

1 site across 1 country: United States