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
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:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014