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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Rush University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01210625
First received: September 23, 2010
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Constipation
Dietary Supplement: Nutrabiotix
Dietary Supplement: Psyllium
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double Blind, Controlled, Dose Ranging Trial to Compare Nutrabiotix Fiber to Psyllium Fiber in Patients Experiencing Constipation.

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Subject satisfaction [ Time Frame: 2011 ] [ Designated as safety issue: No ]
    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:
  • stool weight [ Time Frame: 2011 ] [ Designated as safety issue: No ]
    increased stool weight


Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01210625

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

No publications provided

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01210625     History of Changes
Other Study ID Numbers: Nutrabiotix
Study First Received: September 23, 2010
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antidiarrheals

ClinicalTrials.gov processed this record on September 30, 2014