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

Primary Purpose

Constipation

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Nutrabiotix
Psyllium
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Constipation focused on measuring Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rush University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 23, 2010
Last Updated
June 6, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01210625
Brief Title
Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health
Acronym
NTX
Official Title
A Randomized, Double Blind, Controlled, Dose Ranging Trial to Compare Nutrabiotix Fiber to Psyllium Fiber in Patients Experiencing Constipation.
Study Type
Expanded Access

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation

7. Study Design

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy, asymptomatic 18 to 65 years subjects with BMI 20-30 and self described unsatisfactory bowel habit Exclusion Criteria: Abnormalities in CBC (Hgb <12 g/dL, platelet count <100 000, WBC <4000 or >10 000); Abnormal liver function tests (ALT, AST, alkaline phosphatase, or bilirubin >1.5 times normal range); Abnormal renal function tests (BUN or creatinine >1.5 times normal range); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Brown, M.D.
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28821315
Citation
Rasmussen HE, Hamaker B, Rajan KB, Mutlu E, Green SJ, Brown M, Kaur A, Keshavarzian A. Starch-entrapped microsphere fibers improve bowel habit but do not exhibit prebiotic capacity in those with unsatisfactory bowel habits: a phase I, randomized, double-blind, controlled human trial. Nutr Res. 2017 Aug;44:27-37. doi: 10.1016/j.nutres.2017.05.015. Epub 2017 Jun 2.
Results Reference
derived

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Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

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