Constipation Clinical Trial
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
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.
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: 4.95 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.
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