Clinical trial NCT04283266: Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: probiotics
constipation
FOS
Lead sponsor: Vesale Pharmaceutica
Sponsor class: INDUSTRY
Collaborators: name: Université Catholique de Louvain
name: University of Liege
First posted: 2020-02-25
Enrollment: 27
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Free and informed consent
* Healthy male and female aged 50-70 years
* Patient with ≥1 and ≤3 bowel movements per week in the month before the selection visit and in the two weeks before the enrolment visit.
* At least one in four bowel movements had to involve hard faeces or separate lumps of faeces (Bristol scale class 1 in the three months before enrolment).

Exclusion Criteria:

* Subjects who, in the 30 days before the selection visit or at the time of the visit, had taken drugs, dietary supplements or any foodstuff enhanced in or containing substances, bacteria or yeasts that might have an effect on primary and secondary outcomes.
* Such products were also prohibited throughout the study.
* Subjects on a particular diet or who were under medical treatment that in the investigator's viewpoint might interfere with the evaluation of the study criteria
* Subjects who drink more than three glasses of wine a day or two 25 cl glasses of beer a day, or one glass of spirits per day.
* Subjects who drink more than five cups of coffee per day;
* Subjects with a body mass index (BMI) of more than 30,
* Subjects with type I or II diabetes,
* Subjects with constipation attributable to an organic or anatomical cause;
* Subjects with a history of chronic or inflammatory gastro-intestinal disease;
* Subjects with a history of digestive tract operation including bariatric surgery;

Primary outcomes:
measure: intestinal transit
timeFrame: daily evaluation (day-14 to day 30)
Secondary outcomes:
measure: stool consistency
timeFrame: daily evaluation (day-14 to day 30)
measure: evaluation of quality of life
timeFrame: day 0 and day 30
measure: mood
timeFrame: daily evaluation (day-14 to day 30)
measure: abdominal pain and intestinal discomfort
timeFrame: day -14 and day 30
measure: plasma inflammatory markers (pg/ml)
timeFrame: day 0 and day 30
measure: plasma gut peptides (pg/ml)
timeFrame: day 0 and day 30
measure: microbiota composition
timeFrame: day 0 and day 30
Other outcomes:
Locations:
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