Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

Status:

NO_LONGER_AVAILABLE

Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

Lead Sponsor:

Rush University Medical Center

Conditions:

Constipation

Eligibility:

All Genders

18-65 years

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...

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 microbi...

Eligibility Criteria

Inclusion

Healthy, asymptomatic 18 to 65 years subjects with BMI 20-30 and self described unsatisfactory bowel habit

Exclusion

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.

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT01210625

Last Update

June 8 2023

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