CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 192 enrolled
Drug / intervention
Litesse powder containing 12 g polydextrose +3 moredietary
Likely dose
Litesse powder containing 12 g polydextrosefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02314936
NCT02314936Phase 2Completed
CompareCT.gov

Dose-ranging Efficacy of Supplementation With Polydextrose, a Dietary Fibre, on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Trial

KGK Science Inc.·interventional·Posted Dec 11, 2014·Updated Nov 9, 2018

In Brief

A Phase 2 clinical trial evaluating Litesse powder containing 12 g polydextrose, Litesse powder containing 8 g polydextrose, and 2 other interventions for Functional Constipation. Completed, enrolled 192 participants across 1 site.

Detailed Summary

This study will investigate the effectiveness of Polydextrose, a dietary fiber, at decreasing Colonic Transit Time and the gastrointestinal symptoms of Functional Constipation. One quarter of the subjects will receive 12 g of Polydextrose daily, one quarter will receive 8 g of Polydextrose daily, one quarter will receive 4 g of Polydextrose daily and one quarter will receive a placebo daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFunctional Constipation
CountriesCanada
CollaboratorsDuPont Nutrition and Health

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 11, 2014
Enrollment StartApr 1, 2015
Primary CompletionApr 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.6 years ago

Interventions

Litesse powder containing 12 g polydextrosedietary

12 g polydextrose

Litesse powder containing 8 g polydextrosedietary

8 g polydextrose, 4 g maltodextrin

Litesse powder containing 4 g polydextrosedietary

4 g polydextrose, 8 g maltodextrin

Placebodietary

12 g Maltodextrin