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

Phase 3

Terminated

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Interventions: Drug: LACTEOL® 340 mg
Drug: PLACEBO

Registration Number: NCT01358708

Lead Sponsor: Forest Laboratories

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 26

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LACTEOL® 340 mg	LACTEOL® 340 mg	-
PLACEBO	PLACEBO	-

Primary Outcome Measures

Name	Time	Method
Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)	Weekly Assessment (every 7 days)	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?"

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)	Weekly Assessment (every 7 days)	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?"
Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale	Daily assessment	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.
Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score	Weekly assessment (every 7 days)	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).
Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase	At Screening and End of Double-Blind Treatment 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).
Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score	Weekly assessment (every 7 days)	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).
Stool Characteristics During the Open-Label Treatment Phase Using the BSFS	Daily assessment	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.
Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study	8 weeks	Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study