IQP-CL-101 in IBS Management

InQpharm

Status and phase: Completed; Phase 3

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: IQP-CL-101; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774825

INQ/028111

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

IQP-CL-101

Active Comparator group

Description:

2 softgels twice a day

Treatment:

Dietary Supplement: IQP-CL-101

Placebo

Placebo Comparator group

Description:

2 softgels twice a day

Treatment:

Other: Placebo