Status:
COMPLETED
Dietary Supplementation Effects on Bowel Movement Frequency and Intestinal Biological Markers in Seniors Presenting Slowed Intestinal Transit
Lead Sponsor:
CEN Biotech
Collaborating Sponsors:
Vesale Pharmaceutica
Conditions:
Constipation
Eligibility:
All Genders
50-70 years
Phase:
NA
Brief Summary
This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" o...
Detailed Description
Few studies have been made in France of the epidemiology of constipation although it is a frequent reason for visits to the doctor or for seeking advice from pharmacists. The prevalence of constipatio...
Eligibility Criteria
Inclusion
- healthy male and female volunteers aged 50-70 years 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 and that might have an effect on the gut and more specifically on intestinal transit, digestive comfort, production of gas, or the occurrence of abdominal pain. Such products were also prohibited throughout the study. The same applied to subjects on a particular diet (vegetarian, vegan, hyper-protein, etc.), a low-calorie diet or under medical treatment which in the investigator's view might interfere with the evaluation of the study criteria (antibiotics, corticoids, anticholinergics, antidepressants, antiemetics, diuretics, calcium channel blockers, antiparkinson drugs, antipsychotics, antacids, analgesics, NSAIDS, H2 receptor antagonists, hypnotics, sedatives, iron supplements, opioids and narcotics, laxatives, anti-diarrhoeal drugs, anti-reflux drugs, etc.),
- 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 and those 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 and especially bariatric surgery;
- subjects with a fibre intake exceeding the recommended levels (more than six portions of fruit and vegetables per day according to the PNNS - national nutrition and health programme - questionnaire) or engaging in intense sport for more than 10 hours per week.
Key Trial Info
Start Date :
February 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04304170
Start Date
February 21 2017
End Date
March 15 2018
Last Update
March 11 2020
Active Locations (1)
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1
CEN Nutriment
Dijon, Bourgogne-Franche-Comté, France, 21000