IQP-CL-101 in IBS Management

Double-blind, Randomized, Placebo-controlled, Bicentric Clinical Investigation to Evaluate the Safety and Efficacy of IQP-CL-101 in the Symptomatic Improvement of Irritable Bowel Syndrome (IBS)

After 2 weeks of run-in period, subjects are randomized to either IQP-CL-101 or a matching placebo. Over 8 weeks, the subjects are monitored for improvements in IBS symptoms

Inclusion Criteria:

• Fulfils Rome-III criteria for IBS diagnosis
• Females' agreement to use appropriate birth control methods during the active study period for females of childbearing potential
• Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

• Known sensitivity to any of the ingredients of IQP-CL-101
• Clinically relevant abnormalities in colonoscopy within the last 2 years prior to randomization
• Other causes of IBS symptoms such as inflammatory bowel disease (IBD), microscopic colitis, celiac disease, history of abdominal obstruction, cholecystitis, pancreatitis, ileus, or any gastrointestinal bleeding
• Use of medications that could influence GI functions (e.g. antibiotics, laxatives, opioids, glucocorticoids, anticholinergics, or anti-diarrheals) within 1 month prior to randomization
• Clinically relevant excursions of safety parameters
• Any other conditions deemed relevant by the investigator(s)