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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diarrhea-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: LACTEOL® 340 mg
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LACTEOL® 340 mg<br> | Drug: LACTEOL® 340 mg<br>* 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.<br>|
| Placebo Comparator: PLACEBO<br> | Drug: PLACEBO<br>* 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.<br>|

What is the study measuring?
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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 |