Open Label Study to Assess the Safety and Efficacy of IQP-PO-101 in Regulating Bowel Movement Frequency

Fecha de inicio: 1 de marzo de 2013

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