NCT04231162 (BifidoDigest) is a NA clinical trial of Active product in Functional Constipation, sponsored by Danisco.

Who is sponsoring NCT04231162?

NCT04231162 is sponsored by Danisco.

What drugs are being tested in NCT04231162?

Interventions in NCT04231162: Active product, Control product.

What condition does NCT04231162 study?

NCT04231162 studies Functional Constipation.

Is NCT04231162 still recruiting?

NCT04231162 is currently completed. Last updated 23 February 2022.

Last reviewed 2022-02-23 · How we verify

NCT04231162: BifidoDigest

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 23 February 2022

What this trial tests

NA trial testing Active product in Functional Constipation in 224 participants. Completed in 21 January 2022.

Timeline

16 September 2020

Primary endpoint
21 January 2022

21 January 2022

Quick facts

Lead sponsor	Danisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	224
Start date	16 September 2020
Primary completion	21 January 2022
Estimated completion	21 January 2022
Sites	4 locations across France

Drugs / interventions tested

Active product
Control product — full drug profile →

Conditions studied

Functional Constipation — all drugs for Functional Constipation →

Sponsor

Danisco — full company profile →

Who can join

Adults 18 to 70, any sex, with Functional Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of an 8-Week Bifidobacterium lactis HN019 Supplementation on Functional Constipation: A Multi-Center, Triple-Blind, Randomized, Placebo-Controlled Trial.
Ala-Jaakkola R, Forssten SD, Cheng J, Griffon F, et al · · 2025 · cited 1× · PMID 40320938 · DOI 10.1002/mnfr.70081

Verify or expand the search:

Other trials of Active product

Trials testing the same drug.

NCT06343610 — The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose · NA · completed

Other recruiting trials for Functional Constipation

Currently open trials in the same condition.

NCT07148583 — BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months · NA · recruiting
NCT07091084 — A Study of Herbal Supplements in Cancer Survivors With Constipation · NA · recruiting
NCT06534996 — A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (SCD-2101) for the Functional Constipation in the Elderl · NA · recruiting
NCT04918329 — Functional Digestive Disorders Observatory · recruiting
NCT04547816 — Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse · Phase 3 · recruiting

Other Danisco trials

Trials by the same sponsor.

NCT05150184 — Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults · completed
NCT04125810 — A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress · Phase 2 · completed
NCT03814668 — Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Lactose Solution · NA · completed
NCT03659747 — Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk · NA · completed
NCT03187457 — PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04231162 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Danisco
Last refreshed: 23 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231162.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing