Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health (NTX)
Constipation
About this trial
This is an expanded access trial for Constipation focused on measuring Constipation
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.
Sites / Locations
- Rush University Medical Center