IQP-CL-101 in IBS Management

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: IQP-CL-101; Other: Placebo

• Registration Number: NCT01774825
• Lead Sponsor: InQpharm Group

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-21
• Study First Posted: 2013-01-24
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IQP-CL-101	IQP-CL-101	2 softgels twice a day
Placebo	Placebo	2 softgels twice a day

Primary Outcome Measures

Name	Time	Method
IBS-SSS (Severity Symptom Score)	8 weeks	The questionnaire is to be completed by the subject

Secondary Outcome Measures

Name	Time	Method
Efficacy assessment by subject	8 weeks	The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Safety assessment by subject	8 weeks	The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
IBS-QOL (Quality of Life)	8 weeks	The questionnaire is to be completed by the subject
Efficacy assessment by investigator	8 weeks	The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)
Blood pressure	8 weeks	Sitting blood pressure and heart rate will be measured using standard devices
Adverse events	8 weeks	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
Pain and discomfort diary	8 weeks	The diary is to be completed by the subject on a daily basis
Clinical chemistry	8 weeks	Venous blood samples are obtained at screening and the end of the study (8 weeks)
Safety assessment by investigator	8 weeks	The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)
Fecal calprotectin	8 weeks	The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin
IBS-GIS (Global Improvement Score)	8 weeks	The questionnaire is to be completed by the subject
Full blood count	8 weeks	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

Trial Locations

Locations (1)

Barbara Grube; 🇩🇪 Berlin, Germany