IQP-CL-101 in IBS Management

NCT ID: NCT01774825

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IQP-CL-101

2 softgels twice a day

Group Type ACTIVE_COMPARATOR

IQP-CL-101

Intervention Type DIETARY_SUPPLEMENT

2 softgels twice a day

Placebo

2 softgels twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 softgels twice a day

Interventions

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IQP-CL-101

2 softgels twice a day

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 softgels twice a day

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Grube, MD

Role: PRINCIPAL_INVESTIGATOR

Private Practice

Locations

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Barbara Grube

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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INQ/028111

Identifier Type: -

Identifier Source: org_study_id

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