IQP-CL-101 in IBS Management

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: IQP-CL-101
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IQP-CL-101<br>2 softgels twice a day | Dietary Supplement: IQP-CL-101<br>* 2 softgels twice a day<br>|
| Placebo Comparator: Placebo<br>2 softgels twice a day | Other: Placebo<br>* 2 softgels twice a day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable bowel syndrome, IBS