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

NCT04231162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-02-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • BioFortis

    collaborator OTHER

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Isabelle Metreau, MD · BioFortis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2022-01-21
Completion
2022-01-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04231162 on ClinicalTrials.gov