Constipation, Irregular Bowel Movement Frequency
Conditions
Brief summary
The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency
Interventions
DEVICEIQP-PO-101
Sponsors
InQpharm Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* A subject must have experienced 2 - 4 bowel movements per week and at least 2 of the following symptoms over the preceding 3 months (self-reported): * Excessive straining * Lumpy or hard stools * Sensation of anorectal obstruc-tion * A sense of incomplete evacua-tion of bowel movements * A need for digital manipulation to facilitate evacuation * Recorded between 4 and 9 defecations in the 14-day bowel movement diary during the run-in period * Subjects of childbearing potential must agree to use appropriate contraceptive methods during run-in and treatment period * Commitment to avoid the use of any laxatives and/ or other medicinal products/ supplements that may interfere with bowel movement frequency during the run-in and treatment period * Written informed consent.
Exclusion criteria
* Known sensitivity to the ingredients of the device * Any organic gastrointestinal diseases, congenital or otherwise * Presence of occult blood on screening * Constipation that may have been drug-induced * Use of any laxative/ products that help ease bowel movements within 7 days of the screening visit * Constipation other than idiopathic constipation * Presence of other factor(s) that, in the in-vestigator's judgement, should preclude subject participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel movement frequency | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Straining at the start/ end of defecation | 6 weeks | On a 100mm visual analogue scale (VAS), subjects will rate their feeling of straining at the start/ end of defecation for each bowel movement. |
| Pain during defecation | 6 weeks | On a 100mm visual analogue scale (VAS), subjects will rate their pain during defeca-tion for each bowel movement. |
| Feeling of incomplete evacuation | 6 weeks | With each bowel movement, subjects will mark Yes or No to indicate whether there was a feeling of incomplete evacuation. |
| Evaluation of efficacy by subjects | 4 weeks | The subjects evaluate independently the efficacy of the investigational device (global scaled evaluation with very good, good, moderate and poor). |
| Evaluation of efficacy by investigator | 4 weeks | The investigator evaluates independently the efficacy of the investigational device (global scaled evaluation with very good, good, moderate and poor) |
| Bristol Stool Form Scale | 6 weeks | Subjects will keep a record of their stool form, for each bowel movement. |
| Clinical chemistry | 4 weeks | 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. |
| Safety evaluation by subjects | 4 weeks | The subjects evaluate independently the safety of the investigational device (global scaled evaluation with very good, good, moderate and poor) |
| Safety evaluation by investigators | 4 weeks | The investigators evaluate independently the safety of the investigational device (global scaled evaluation with very good, good, moderate and poor) |
| Adverse events | 6 weeks | — |
| Full blood count | 4 weeks | Venous blood samples are obtained at screening and the end of the treatment period (4 weeks) |
Countries
Germany
Outcome results
None listed