IQP-CL-101 in IBS Management

Irritable Bowel Syndrome Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774825
• Other study ID #: INQ/028111
• Status: Completed
• Phase: Phase 3
• First received: January 21, 2013
• Last updated: March 25, 2015
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• IQP-CL-101
2 softgels twice a day

Other:
• Placebo
2 softgels twice a day

Locations

Country	Name	City	State
Germany	Barbara Grube	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS-SSS (Severity Symptom Score)	The questionnaire is to be completed by the subject	8 weeks	No
Secondary	IBS-GIS (Global Improvement Score)	The questionnaire is to be completed by the subject	8 weeks	No
Secondary	IBS-QOL (Quality of Life)	The questionnaire is to be completed by the subject	8 weeks	No
Secondary	Pain and discomfort diary	The diary is to be completed by the subject on a daily basis	8 weeks	No
Secondary	Efficacy assessment by investigator	The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)	8 weeks	No
Secondary	Efficacy assessment by subject	The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)	8 weeks	No
Secondary	Full blood count	After sampling, venous blood samples will be transported on same day in cooler boxes to a central laboratory for analysis of hemoglobin, hematocrit, erythrocytes, thrombocytes, and leucocytes	8 weeks	Yes
Secondary	Clinical chemistry	Venous blood samples are obtained at screening and the end of the study (8 weeks)	8 weeks	Yes
Secondary	Fecal calprotectin	The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin	8 weeks	Yes
Secondary	Blood pressure	Sitting blood pressure and heart rate will be measured using standard devices	8 weeks	Yes
Secondary	Safety assessment by subject	The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)	8 weeks	Yes
Secondary	Safety assessment by investigator	The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)	8 weeks	Yes
Secondary	Adverse events	At all visits, subjects will be asked if any AE has occurred; such events will be recorded in the source documents and case report forms	8 weeks	Yes