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

NCT01358708 | Terminated Phase 3 Results

• 1 other identifier: MA-LA-IBS09-01
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 8

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).

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)

  Weekly Assessment (every 7 days)

• Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score

  Weekly assessment (every 7 days)

• Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale

  Daily assessment

• Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase

  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

  Weekly assessment (every 7 days)

Study Arms (2)

LACTEOL® 340 mg

EXPERIMENTAL

Drug: LACTEOL® 340 mg

PLACEBO

PLACEBO COMPARATOR

Drug: PLACEBO

Interventions

LACTEOL® 340 mg DRUG

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.

LACTEOL® 340 mg

PLACEBO DRUG

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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (8)

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Colombes, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Rouen, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Mannheim, Germany

Location

MeSH Terms

Interventions

Lacteol

Limitations and Caveats

Because of early termination of this trial, the number of subjects analyzed was too small to perform statistical analyses and draw conclusions relative to the efficacy and safety of LACTEOL®.

Results Point of Contact

• Title: Robert Winkler MD, VP, Clinical Development and Operations
• Organization: Aptalis Pharma US, Inc.

rwinkler@aptalispharma.com

(908) 429-4479

Study Officials

• Ivan T Shaw, PhD

  Axcan Pharma Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2010
• First Posted: May 24, 2011
• Study Start: June 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 21, 2017
• Results First Posted: December 30, 2013

Record last verified: 2017-02

Locations

FR (5); DE (3)