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NCT04304170

Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit

Completed NA Last updated 11 March 2020
What this trial tests

NA trial testing VES002 in Constipation in 27 participants. Completed in 15 March 2018.

Timeline
21 February 2017
Primary endpoint
15 March 2018
15 March 2018

Quick facts

Lead sponsorCEN Biotech
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment27
Start date21 February 2017
Primary completion15 March 2018
Estimated completion15 March 2018
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

CEN Biotech — full company profile →

Who can join

Adults 50 to 70, any sex, with Constipation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet and a placebo group treated with a comparative product hat looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose). The claim investigated corresponds to the section of the new EFSA (European Food Safety Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".

Publications & conference data

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

  1. Gut Microbiome-Brain Alliance: A Landscape View into Mental and Gastrointestinal Health and Disorders.
    Sasso JM, Ammar RM, Tenchov R, Lemmel S, et al · · 2023 · cited 100× · PMID 37156006 · DOI 10.1021/acschemneuro.3c00127

Verify or expand the search:

Other recruiting trials for Constipation

Currently open trials in the same condition.

Other CEN Biotech trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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