NCT04231162

Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation

Effect of an 8-week Bifidobacterium Lactis HN019 Supplementation on Functional Constipation: A Double-blind, Randomized; Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This prospective, two-arm (parallel groups), double-blind, randomized, placebo-controlled, multi-center clinical trial will investigate the effects of an 8-week Bifidobacterium lactis HN019 supplementation on stool frequency and on other constipation parameters in adults suffering from functional constipation according to ROME III criteria. The hypothesis is that Bifidobacterium lactis HN019 is superior, in comparison with a placebo, for the increase of stool frequency of at least 1 stool per week.

Conditions

• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Active product	Bifidobacterium lactis HN019 (probiotic powder). One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
DIETARY_SUPPLEMENT	Control product	Placebo. One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.

Timeline

• Start date: 2020-09-16
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2020-01-18
• Last updated: 2022-02-23

Locations

4 sites across 1 country: France