Clinical trial NCT01358708: Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) With LACTEOL® 340 mg
Official title: Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diarrhea-predominant Irritable Bowel Syndrome
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)
timeFrame: Weekly Assessment (every 7 days)
Secondary outcomes:
measure: Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)
timeFrame: Weekly Assessment (every 7 days)
measure: Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
timeFrame: Weekly assessment (every 7 days)
measure: Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale
timeFrame: Daily assessment
measure: Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase
timeFrame: At Screening and End of Double-Blind Treatment Phase
measure: Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score
timeFrame: Weekly assessment (every 7 days)
measure: Stool Characteristics During the Open-Label Treatment Phase Using the BSFS
timeFrame: Daily assessment
measure: Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
city: Colombes
country: France
city: Marseille
country: France
city: Nice
country: France
city: Rouen
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Mannheim
country: Germany
Study officials:
affiliation: Axcan Pharma Inc.
name: Ivan T Shaw, PhD
role: STUDY_DIRECTOR
References: