IQP-CL-101 in IBS Management

InQpharm Group100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Irritable Bowel Syndrome

Interventions

IQP-CL-101DIETARY_SUPPLEMENT

2 softgels twice a day

PlaceboOTHER

2 softgels twice a day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Barbara Grube

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

IBS-SSS (Severity Symptom Score)

The questionnaire is to be completed by the subject

Time frame: 8 weeks

Secondary Outcomes

IBS-GIS (Global Improvement Score)

The questionnaire is to be completed by the subject

Time frame: 8 weeks

IBS-QOL (Quality of Life)

The questionnaire is to be completed by the subject

Time frame: 8 weeks

Pain and discomfort diary

The diary is to be completed by the subject on a daily basis

Time frame: 8 weeks

Efficacy assessment by investigator

The investigator rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)

Time frame: 8 weeks

Efficacy assessment by subject

The subject rates the efficacy of the investigational product using a 4-point Likert scale (poor, moderate, good, very good)

Time frame: 8 weeks

Full blood count

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

Time frame: 8 weeks

Clinical chemistry

Venous blood samples are obtained at screening and the end of the study (8 weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.