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Completed

NCT Number: NCT01774825

IQP-CL-101 in IBS Management

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barbara Grube

Berlin, State of Berlin, 10709, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

IQP-CL-101

Dietary Supplement

2 softgels twice a day

Placebo

Other

2 softgels twice a day

Primary outcomes

  1. IBS-SSS (Severity Symptom Score)

    Time frame: 8 weeks

    The questionnaire is to be completed by the subject

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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