Status:
COMPLETED
Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults
Lead Sponsor:
Vesale Pharmaceutica
Collaborating Sponsors:
Université Catholique de Louvain
University of Liege
Conditions:
Constipation
Eligibility:
All Genders
50-70 years
Phase:
NA
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 characteriz...
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 end...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04283266
Start Date
June 12 2016
End Date
January 31 2019
Last Update
April 3 2020
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