IQP-CL-101 in IBS Management - Full Text View

Purpose

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

Condition	Intervention	Phase
Irritable Bowel Syndrome	Dietary Supplement: IQP-CL-101 Other: Placebo	Phase 3

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

Further study details as provided by InQpharm Group:

Primary Outcome Measures:

IBS-SSS (Severity Symptom Score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The questionnaire is to be completed by the subject

Secondary Outcome Measures:

IBS-GIS (Global Improvement Score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The questionnaire is to be completed by the subject
IBS-QOL (Quality of Life) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The questionnaire is to be completed by the subject
Pain and discomfort diary [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The diary is to be completed by the subject on a daily basis
Efficacy assessment by investigator [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Efficacy assessment by subject [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Full blood count [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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
Clinical chemistry [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Venous blood samples are obtained at screening and the end of the study (8 weeks)
Fecal calprotectin [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin
Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Sitting blood pressure and heart rate will be measured using standard devices
Safety assessment by subject [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Safety assessment by investigator [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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

Estimated Enrollment:	100
Study Start Date:	January 2013
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774825

Contacts

Contact: Barbara Grube, MD

+49 30/892 10 30

bgrube@web.de

Locations

Germany
Barbara Grube	Recruiting
Berlin, Germany, 10709
Contact: Barbara Grube, MD bgrube@web.de

Sponsors and Collaborators

InQpharm Group

Investigators

Principal Investigator:

Barbara Grube, MD

Private practice

More Information

No publications provided

Responsible Party:	InQpharm Group
ClinicalTrials.gov Identifier:	NCT01774825 History of Changes
Other Study ID Numbers:	INQ/028111
Study First Received:	January 21, 2013
Last Updated:	January 21, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by InQpharm Group:

Irritable bowel syndrome
IBS

Additional relevant MeSH terms:

Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases

Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013