Irritable Bowel Syndrome
Conditions
Keywords
Irritable bowel syndrome, IBS
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
Interventions
DIETARY_SUPPLEMENTIQP-CL-101
2 softgels twice a day
OTHERPlacebo
2 softgels twice a day
Sponsors
InQpharm Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IBS-SSS (Severity Symptom Score) | 8 weeks | The questionnaire is to be completed by the subject |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBS-QOL (Quality of Life) | 8 weeks | The questionnaire is to be completed by the subject |
| Pain and discomfort diary | 8 weeks | The diary is to be completed by the subject on a daily basis |
| 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) |
| 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) |
| 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 |
| IBS-GIS (Global Improvement Score) | 8 weeks | The questionnaire is to be completed by the subject |
| Fecal calprotectin | 8 weeks | The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin |
| Blood pressure | 8 weeks | Sitting blood pressure and heart rate will be measured using standard devices |
| 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) |
| 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) |
| 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 |
| Clinical chemistry | 8 weeks | Venous blood samples are obtained at screening and the end of the study (8 weeks) |
Countries
Germany
Outcome results
None listed