Ignite Creation Date:
2024-05-06 @ 2:23 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04304170
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2020-02-26
Brief Title:
Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
Sponsor:
CEN Biotech
Organization:
CEN Biotech
Study Overview
Official Title:
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
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 495 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
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 22 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None