Trials Sponsors Conditions Drugs Pricing

You may not qualify if:

Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance).
History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results.
Recent history (within 6 weeks of screening, visit 1) of constipation (defined as \<3 bowel movements per week), and/or diarrhea (defined as ≥3 loose or liquid stools/d).
Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea.
Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
Daily use of antacids, proton pump inhibitors, H2 blockers.
Recent use of antibiotics (within 3 months of visit 2, day 0).
Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements.
Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet.
Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean.
Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg at visit 1, day -7). One re-test will be allowed on a separate day prior to visit 2 (day 0), for subjects whose blood pressure exceeds either of these cut points at visit 1, in the judgment of the Investigator.
History of cancer in the prior two years, except for non-melanoma skin cancer.
Any major trauma or surgical event within 2 months of visit 2, day 0.
Females who are pregnant, planning to be pregnant during the study period, lactating, or women of childbearing potential who are unwilling to commit to use of a medically approved form of contraception throughout the study period. The method of birth control must be recorded in the source documentation.
Exposure to any non-registered drug product within 30 days prior to the screening visit.
+3 more criteria

Acute Gastrointestinal Tolerability Following a Single Serving of a Novel Dietary Fiber

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

Negative control

Positive Fiber control

Novel Fiber 10g

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Novel Fiber 30g

Novel Fiber 50g

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (5)

Negative control

Positive Fiber control

Novel Fiber 10g

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Novel Fiber 30g

Novel Fiber 50g

You may not qualify if:

Source record