NCT02314936

Dose-ranging Efficacy of Polydextrose Supplement on Colonic Transit Time and Symptoms in Adults With Functional Constipation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: KGK Science Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Litesse powder containing 12 g polydextrose	12 g polydextrose
DIETARY_SUPPLEMENT	Litesse powder containing 8 g polydextrose	8 g polydextrose, 4 g maltodextrin
DIETARY_SUPPLEMENT	Litesse powder containing 4 g polydextrose	4 g polydextrose, 8 g maltodextrin
DIETARY_SUPPLEMENT	Placebo	12 g Maltodextrin

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2014-12-11
• Last updated: 2018-11-09
• Results posted: 2018-11-09

Locations

1 site across 1 country: Canada