Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health (NTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01210625
Recruitment Status : Active, not recruiting
First Posted : September 28, 2010
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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).

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Nutrabiotix Dietary Supplement: Psyllium Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Double Blind, Controlled, Dose Ranging Trial to Compare Nutrabiotix Fiber to Psyllium Fiber in Patients Experiencing Constipation.
Study Start Date : July 2010
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Psyllium
Subjects will take 4 capsules containing 1 gram psyllium fiber 3 times a day (12g total per day)
Dietary Supplement: Psyllium
12g total per day (4 capsules containing 1 gram psyllium fiber 3 times a day)

Experimental: Nutrabiotix 9g
Subjects take a total of 9g of Nutrabiotix a day (3 capsules of 1g Nutrabiotix 3 times a day)
Dietary Supplement: Nutrabiotix
Fiber supplement: 9mg or 12mg

Experimental: Nutrabiotix 12g
Subjects take a total of 12g of Nutrabiotix a day (4 capsules of 1g Nutrabiotix 3 times a day)
Dietary Supplement: Nutrabiotix
Fiber supplement: 9mg or 12mg

Primary Outcome Measures :
  1. Subject satisfaction [ Time Frame: 2011 ]
    Subjects self report improvement of BM, Nutrabiotix is better tolerated [less side effects per subjects self report] and has a better prebiotic activity [higher stool SCFA/indoles ratios as the primary outcome; comparably more Bifidobacteria as the secondary outcome].

Secondary Outcome Measures :
  1. stool weight [ Time Frame: 2011 ]
    increased stool weight

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy, asymptomatic 18 to 65 years subjects with BMI 20-30 and self described unsatisfactory bowel habit

Exclusion Criteria:

  1. Abnormalities in CBC (Hgb <12 g/dL, platelet count <100 000, WBC <4000 or >10 000);
  2. Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin >1.5 times normal range);
  3. Abnormal renal function tests (BUN or creatinine >1.5 times normal range);
  4. Low serum albumin (<3 g/dL);

5) Abnormal TSH level;

(6) High CRP;

(7) Significant GI symptoms (except for constipation or occasional rectal bleeding due to hemorrhoids);

(8) Prior intestinal resection;

(9) Patient history of GI diseases [except for hemorrhoids or occasional (<3 times a week) heartburn];

(10) Antibiotic use within last 12 weeks prior to enrollment;

(11) Lean (BMI <25) or obese (BMI>30) subjects because obesity could be associated with abnormal microbiota;

(12) Significant cardiac or respiratory diseases (defined by requiring daily medication for management of their diseases);

(13) Severe hypertension (defined as uncontrolled hypertension in spite of therapy, or requirement of more than one medication to treat hypertension; well-controlled, mild hypertension may be included);

(14) Insulin-requiring and/or poorly controlled diabetes (well-controlled diabetics with HbA1c <6 may be enrolled);

(15) Significant psychological disorders;

(16) Drug and/or alcohol abuse;

(17) Unwillingness to consent to the study;

(18) Plan to have a major change of the dietary habit during the following 5 months;

(19) Subjects younger than 18 or older than 65. Older subjects are excluded in this initial study because of high co-morbidity in older subjects. Children are excluded for this initial Phase I study where the safety is not established;

(20) Pregnant and lactating women due to lack of information about safety of the product in pregnant and lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01210625

United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: Michael Brown, M.D. Rush University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rush University Medical Center Identifier: NCT01210625     History of Changes
Other Study ID Numbers: Nutrabiotix
First Posted: September 28, 2010    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by Rush University Medical Center:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Calcium polycarbophil
Gastrointestinal Agents