IQP-PO-101 for the Regulation of Bowel Movement Frequency

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

The purpose of the study is to evaluate the safety and efficacy of IQP-PO-101 in regulating the bowel movement frequency

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