IQP-CL-101 in IBS Management

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01774825
• Date of registration: 21/01/2013
• Prospective Registration: No
• Primary sponsor: InQpharm Group
• Public title: IQP-CL-101 in IBS Management
• Scientific title: 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)
• Date of first enrolment: January 2013
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01774825
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Barbara Grube, MD
• Affiliation: Private practice

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome

Intervention(s)

Dietary Supplement: IQP-CL-101

Other: Placebo

Primary Outcome(s)

IBS-SSS (Severity Symptom Score) [Time Frame: 8 weeks]

Secondary Outcome(s)

IBS-QOL (Quality of Life) [Time Frame: 8 weeks]

Efficacy assessment by subject [Time Frame: 8 weeks]

Fecal calprotectin [Time Frame: 8 weeks]

Safety assessment by subject [Time Frame: 8 weeks]

Clinical chemistry [Time Frame: 8 weeks]

Pain and discomfort diary [Time Frame: 8 weeks]

Efficacy assessment by investigator [Time Frame: 8 weeks]

Safety assessment by investigator [Time Frame: 8 weeks]

Blood pressure [Time Frame: 8 weeks]

Full blood count [Time Frame: 8 weeks]

Adverse events [Time Frame: 8 weeks]

IBS-GIS (Global Improvement Score) [Time Frame: 8 weeks]

Secondary ID(s)

INQ/028111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors