IQP-CL-101 in IBS Management

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InQpharm

Status and phase

Completed
Phase 3

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: IQP-CL-101
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01774825
INQ/028111

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

IQP-CL-101
Active Comparator group
Description:
2 softgels twice a day
Treatment:
Dietary Supplement: IQP-CL-101
Placebo
Placebo Comparator group
Description:
2 softgels twice a day
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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