Ignite Creation Date:
2024-05-06 @ 2:20 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04283266
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2019-11-12
Brief Title:
Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults
Sponsor:
Vesale Pharmaceutica
Organization:
Vesale Pharmaceutica
Study Overview
Official Title:
Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria on Stool Frequency and Biological Markers in Middle-aged Adults a Randomized Double-blind Placebo-controlled Clinical Trial
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:
The aim of the study is to evaluate the impact of a synbiotic containing fructo-oligosaccharides FOS and Bifidobacteria VES002 LMG P-28149 on intestinal transit in middle-aged subjects characterized by a low number of defecations per week
Detailed Description:
Middle-aged subjects who met ROME III criteria for constipation received daily two sachets of either synbiotic or for 5 days then they received daily 1 sachet for the next 25 days
The primary endpoint of this trial is to evaluate the effect of supplementation in synbiotic containing fructo-oligosaccharides FOS and Bifidobacteria VES002 LMG P-28149 on intestinal transit in middle-aged subjects characterized by a 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 composition The safety of product use and compliance are also evaluated
Synbiotic group The dietary supplement under study was composed of fructo-oligosaccharides - FOS 495 gr sachet and Bifidobacterium animalis lactis VES002 LMG P-28149 5 billion sachet Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days
Placebo group The placebo looked strictly identical to the synbiotic and contained only excipients 60 maltodextrin 40 sucrose Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days
The primary endpoint of this trial is to evaluate the effect of supplementation in synbiotic containing fructo-oligosaccharides FOS and Bifidobacteria VES002 LMG P-28149 on intestinal transit in middle-aged subjects characterized by a 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 composition The safety of product use and compliance are also evaluated
Synbiotic group The dietary supplement under study was composed of fructo-oligosaccharides - FOS 495 gr sachet and Bifidobacterium animalis lactis VES002 LMG P-28149 5 billion sachet Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days
Placebo group The placebo looked strictly identical to the synbiotic and contained only excipients 60 maltodextrin 40 sucrose Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days
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