NCT04304170

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

Randomized, Double-blind, Placebo-controlled Clinical Trial of the Effect of Dietary Supplementation With Bifidobacteria and Fructo-oligosaccharides (FOS) on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: CEN Biotech · Industry
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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".

Detailed description

Few studies have been made in France of the epidemiology of constipation although it is a frequent reason for visits to the doctor or for seeking advice from pharmacists. The prevalence of constipation in European and North American populations is reportedly of the order of 15% on average and it is 2.2 times more frequent among women than men. Hammond and Harari show there is an increased frequency of constipation from the age of 50 years onwards and that it substantially impacts quality of life. This can be explained in part by significant changes in the workings of the gastro-intestinal system in the course of normal ageing with reduced numbers of bifidobacteria in the gut. These disorders are a major reason for taking oral and local drugs that are not without their side-effects and entail substantial healthcare costs. lifestyle rules combining appropriate fluid intake, regular physical activity and a high-fibre diet should be systematically recommended to such patients. "Symbiotic" dietary supplements combining probiotics and prebiotics may also be recommended provided that their effects have been properly validated. The symbiotic combination proposed in this clinical study is made up of fructo-oligosaccharides (FOS) sold as Actilight FOS (Beghin Say) and bifidobacteria BB12. Each of these components has been the subject of numerous studies showing improved intestinal transit especially in the elderly. A recent meta-analysis of the main studies published in Medline, Embase and The Cochrane Library has concluded that symbiotic with FOS and probiotics have a positive effect on bowel movement frequency and stool consistency. The change in European regulations requires that clinical studies be conducted to secure EFSA claims for these dietary supplements. Such studies should also show an objective clinical benefit and factors such as a dose-dependent effect and/or the modification of biological markers that might confirm any such positive effect. This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation serves this purpose. The claim investigated corresponds to the section of the new EFSA guidance of 2016 entitled "Claims on maintenance of normal defecation". The primary endpoint of this trial is to evaluate the effect of supplementation in symbiotic on intestinal transit of subjects with few bowel movements per week. The secondary endpoints are to evaluate: * both clinical criteria such as changes in stool appearance, quality of life and mood, relief and satisfaction of participants; * and biological criteria such as changes in markers of gut function, low-grade chronic inflammation markers and gut microbiota markers. The safety of product use and compliance are also evaluated.

Conditions

• Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	VES002	The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
OTHER	Placebo	The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.

Timeline

• Start date: 2017-02-21
• Primary completion: 2018-03-15
• Completion: 2018-03-15
• First posted: 2020-03-11
• Last updated: 2020-03-11

Locations

1 site across 1 country: France