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

Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy

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).

Study Overview

• Status: Terminated
• Conditions: Diarrhea-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: LACTEOL® 340 mg; Drug: PLACEBO

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
  • Colombes, France
  • Marseille, France
  • Nice, France
  • Rouen, France
• Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Mannheim, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LACTEOL® 340 mg	Drug: 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.
Placebo Comparator: PLACEBO	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)	Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"	Weekly Assessment (every 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)	Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"	Weekly Assessment (every 7 days)
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score	The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).	Weekly assessment (every 7 days)
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale	The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.	Daily assessment
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase	The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).	At Screening and End of Double-Blind Treatment Phase
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score	The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).	Weekly assessment (every 7 days)
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS	The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.	Daily assessment
Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study	Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study	8 weeks

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Study Director: Ivan T Shaw, PhD, Axcan Pharma inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 16, 2010
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: MA-LA-IBS09-01