The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Analyze & Realize Ag
Berlin, State of Berlin, Germany
Bowel movement frequency
Subjects will keep a record of the number of bowel movements, if any, from 00:00 hours to 23:59 hours (midnight to midnight) daily.
Time frame: 6 weeks
Bristol Stool Form Scale
Subjects will keep a record of their stool form, for each bowel movement.
Time frame: 6 weeks
Straining at the start/ end of defecation
On a 100mm visual analogue scale (VAS), subjects will rate their feeling of straining at the start/ end of defecation for each bowel movement.
Time frame: 6 weeks
Pain during defecation
On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement.
Time frame: 6 weeks
Feeling of incomplete evacuation
With each bowel movement, subjects will mark "Yes" or "No" to indicate whether there was a feeling of incomplete evacuation.
Time frame: 6 weeks
Evaluation of efficacy by subjects
The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").
Time frame: 4 weeks
Evaluation of efficacy by investigator
The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time frame: 4 weeks
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Full blood count
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks)
Time frame: 4 weeks
Clinical chemistry
Venous blood samples are obtained at screening and the end of the treatment period (4 weeks) for measurements of uric acid, HbA1c and lipid profiles. An analysis will be done based on the change between the 2 periods.
Time frame: 4 weeks
Safety evaluation by subjects
The subjects evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time frame: 4 weeks
Safety evaluation by investigators
The investigators evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor")
Time frame: 4 weeks
Adverse events
Time frame: 6 weeks