Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg

NCT ID: NCT01358708

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-09-30

Brief Summary

Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

Detailed Description

This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.

Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.

Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.

Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.

Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LACTEOL® 340 mg

Group Type: EXPERIMENTAL

LACTEOL® 340 mg

Intervention Type: DRUG

LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.

PLACEBO

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.

Interventions

LACTEOL® 340 mg

LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.

Intervention Type: DRUG

PLACEBO

Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• IBS-D diagnosis using the Rome III questionnaire
• IBS Symptoms Severity Scale (IBS-SSS) score ranging between 100 and 400
• Bristol Stool Form Scale score exceeding two (> 2) but less than seven (< 7)
• Stable diet
• Mental and legal ability to sign informed consent

Exclusion Criteria

• Diagnosis of Inflammatory Bowel Disease (IBD)
• Chronic use of systemic steroids
• Diagnosis of autoimmune Diseases or Disorders
• Invasive abdominal surgery
• Use of antibiotics prior to screening
• Allergy to active substance or any other ingredient in LACTEOL® 340 mg
• Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
• Diagnosis of exocrine pancreatic insufficiency
• Use of any experimental drug within the 30 days prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan T Shaw, PhD

Role: STUDY_DIRECTOR

Axcan Pharma Inc.

Locations

Bordeaux, , France

Colombes, , France

Marseille, , France

Nice, , France

Rouen, , France

Berlin, , Germany

Hamburg, , Germany

Mannheim, , Germany

Countries

France; Germany

Other Identifiers

MA-LA-IBS09-01

Identifier Type: -

Identifier Source: org_study_id