Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
Last updated on July 2021Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 184
Summary
- Conditions
- Functional Constipation
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber produ...
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Tracking Information
- NCT #
- NCT01540669
- Collaborators
- Sprim Advanced Life Sciences
- Investigators
- Principal Investigator: Silvio Danese, MD Istituto Clinico Humanitas
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