Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT04283266
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: 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.
Study:
NCT04283266
Study Brief:
Protocol Section:
NCT04283266