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IQP-CL-101 in IBS Management

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ClinicalTrials.gov Identifier: NCT01774825
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

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




Primary Outcome Measures :
  1. IBS-SSS (Severity Symptom Score) [ Time Frame: 8 weeks ]
    The questionnaire is to be completed by the subject


Secondary Outcome Measures :
  1. IBS-GIS (Global Improvement Score) [ Time Frame: 8 weeks ]
    The questionnaire is to be completed by the subject

  2. IBS-QOL (Quality of Life) [ Time Frame: 8 weeks ]
    The questionnaire is to be completed by the subject

  3. Pain and discomfort diary [ Time Frame: 8 weeks ]
    The diary is to be completed by the subject on a daily basis

  4. Efficacy assessment by investigator [ Time Frame: 8 weeks ]
    The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)

  5. Efficacy assessment by subject [ Time Frame: 8 weeks ]
    The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)

  6. Full blood count [ Time Frame: 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

  7. Clinical chemistry [ Time Frame: 8 weeks ]
    Venous blood samples are obtained at screening and the end of the study (8 weeks)

  8. Fecal calprotectin [ Time Frame: 8 weeks ]
    The samples will be later tested by an enzyme immunoassay (ELISA) specific for calprotectin

  9. Blood pressure [ Time Frame: 8 weeks ]
    Sitting blood pressure and heart rate will be measured using standard devices

  10. Safety assessment by subject [ Time Frame: 8 weeks ]
    The subject rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)

  11. Safety assessment by investigator [ Time Frame: 8 weeks ]
    The investigator rates the safety of the IP using a 4-point Likert scale (poor, moderate, good, very good)

  12. Adverse events [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774825


Locations
Germany
Barbara Grube
Berlin, Germany, 10709
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Barbara Grube, MD Private practice

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01774825     History of Changes
Other Study ID Numbers: INQ/028111
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by InQpharm Group:
Irritable bowel syndrome
IBS

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases