IQP-CL-101 in IBS Management

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01774825
First received: January 21, 2013
Last updated: January 13, 2014
Last verified: January 2014
  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)

Resource links provided by NLM:


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


Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Barbara Grube
Berlin, Germany, 10709
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 13, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 18, 2014