Text Size

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

This study has been terminated.
(Administrative reasons)
Sponsor:
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01358708
First received: May 16, 2010
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

Irritable bowel syndrome, especially the diarrhea-predominant subtype (IBS-D) is a complex condition that remains sub-optimally treated as existing therapies for IBS have been considered to be only moderately effective. No currently approved therapy is widely used for the treatment of IBS and new therapies are being constantly sought.

Even though this is a pilot study, the robust methodology proposed(randomized, placebo-controlled, ROME III selection criteria, symptoms measurements using standardized IBS tools) will permit to adequately measure efficacy of LACTEOL 340 mg in the treatment of IBS-D and provide guidance on the need for future clinical development to relieve the burden of suffering patients.


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

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Aptalis Pharma:

Primary Outcome Measures:
  • Global Assessment of Relief using the Subject Global Assessment [ Time Frame: Weekly Assessment (every 7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual symptom severity score using the IBS Symptom Severity Scale [ Time Frame: Weekly assessment (every 7 days) ] [ Designated as safety issue: No ]
  • Stool characteristics using the Bristol Stool Form Scale [ Time Frame: Daily assessment (every day) ] [ Designated as safety issue: No ]
  • Clinical laboratory parameters using Chemistry and Hematology [ Time Frame: Monthly (every 4 weeks) ] [ Designated as safety issue: Yes ]
    Monitoring and evaluation of chemistry and hematology values for changes against baseline values.


Estimated Enrollment: 60
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LACTEOL® 340 mg
LACTEOL® active medication
 Drug: LACTEOL® 340 mg
LACTEOL® study medication (either LACTEOL® 340 mg or 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.
Placebo Comparator: LACTEOL® Placebo Drug: LACTEOL® 340 mg
LACTEOL® study medication (either LACTEOL® 340 mg or 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 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.

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:

  1. IBS-D diagnosis using the Rome III questionnaire
  2. IBS symptoms severity and stool characteristics (using IBS-Symptom Severity Scale and Bristol Stool Chart)
  3. Mental and legal ability to sign informed consent

Exclusion Criteria:

  1. Diagnosis of Inflammatory Bowel Disease (IBD)
  2. Chronic use of systemic steroids
  3. Diagnosis of autoimmune Diseases or Disorders
  4. Invasive abdominal surgery
  5. Use of antibiotics prior to screening
  6. Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance
  7. Use of any experimental drug within the 30 days prior to screening
  Contacts and Locations
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: Ivan T. Shaw, PhD, Axcan Pharma
ClinicalTrials.gov Identifier: NCT01358708     History of Changes
Other Study ID Numbers: MA-LA-IBS09-01
Study First Received: May 16, 2010
Last Updated: November 16, 2012
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
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013