Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT04283266
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;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04283266
Study Brief:
Protocol Section:
NCT04283266