Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

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.