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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: IQP-CL-101; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10709
    • Barbara Grube

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IQP-CL-101; 2 softgels twice a day	Dietary supplement: IQP-CL-101; 2 softgels twice a day
Placebo Comparator: Placebo; 2 softgels twice a day	Other: Placebo; 2 softgels twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-SSS (Severity Symptom Score)	The questionnaire is to be completed by the subject	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-GIS (Global Improvement Score)	The questionnaire is to be completed by the subject	8 weeks
IBS-QOL (Quality of Life)	The questionnaire is to be completed by the subject	8 weeks
Pain and discomfort diary	The diary is to be completed by the subject on a daily basis	8 weeks
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
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
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
Clinical chemistry	Venous blood samples are obtained at screening and the end of the study (8 weeks)	8 weeks
Fecal calprotectin	The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin	8 weeks
Blood pressure	Sitting blood pressure and heart rate will be measured using standard devices	8 weeks
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
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
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

Collaborators and Investigators

• Sponsor: InQpharm Group
• Investigators: Principal Investigator: Barbara Grube, MD, Private Practice

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 21, 2013
• First Posted (Estimate): January 24, 2013

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: IBS; Irritable bowel syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: INQ/028111