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

This study has been terminated.
(Administrative reasons)
Sponsor:
Information provided by (Responsible Party):
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01358708
First received: May 16, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention Phase
Diarrhea-predominant Irritable Bowel Syndrome
Drug: LACTEOL® 340 mg
Drug: PLACEBO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Diarrhea-predominant Irritable Bowel Syndrome With LACTEOL® 340 mg: A Pilot Study Evaluating Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Aptalis Pharma:

Primary Outcome Measures:
  • Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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?"

  • Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score [ Time Frame: Weekly assessment (every 7 days) ] [ Designated as safety issue: No ]
    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 Double-Blind Treatment Phase Using the Bristol Stool Form Scale [ Time Frame: Daily assessment ] [ Designated as safety issue: No ]
    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.

  • Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase [ Time Frame: At Screening and End of Double-Blind Treatment Phase ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weekly assessment (every 7 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily assessment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study


Enrollment: 26
Study Start Date: June 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358708

Locations
France
Bordeaux, France
Colombes, France
Marseille, France
Nice, France
Rouen, France
Germany
Berlin, Germany
Hamburg, Germany
Mannheim, Germany
Sponsors and Collaborators
Aptalis Pharma
Investigators
Study Director: Ivan T Shaw, PhD Axcan Pharma Inc.
  More Information

No publications provided

Responsible Party: Aptalis Pharma
ClinicalTrials.gov Identifier: NCT01358708     History of Changes
Other Study ID Numbers: MA-LA-IBS09-01
Study First Received: May 16, 2010
Results First Received: June 20, 2013
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014