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Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Status
Sponsorlar
Rush University Medical Center

Açar sözlər

Mücərrəd

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).

Təsvir

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.

Tarixlər

Son Doğrulandı: 03/31/2018
İlk təqdim: 09/22/2010
Təxmini qeydiyyat təqdim edildi: 09/26/2010
İlk Göndərmə: 09/27/2010
Son Yeniləmə Göndərildi: 04/10/2018
Son Yeniləmə Göndərildi: 04/11/2018
Həqiqi Təhsilin Başlama Tarixi: 06/30/2010
Təxmini İlkin Tamamlanma Tarixi: 09/30/2019
Təxmini İşin Tamamlanma Tarixi: 09/30/2019

Vəziyyət və ya xəstəlik

Constipation

Müdaxilə / müalicə

Dietary Supplement: Nutrabiotix

Dietary Supplement: Psyllium

Faza

Faza 1/Faza 2

Qol Qrupları

QolMüdaxilə / müalicə
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)
Experimental: Nutrabiotix 12g
Subjects take a total of 12g of Nutrabiotix a day (4 capsules of 1g Nutrabiotix 3 times a day)

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar 18 Years Üçün 18 Years
Təhsilə Uyğun CinslərAll
Sağlam Könüllüləri qəbul edirBəli
Kriteriyalar

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.

Nəticə

İlkin nəticə tədbirləri

1. Subject satisfaction [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].

İkincili Nəticə Tədbirləri

1. stool weight [2011]

increased stool weight

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