Diarrhea-predominant Irritable Bowel Syndrome MedDRA version: 12.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome
Conditions
Interventions
Trade Name: LACTEOL 340 mg, gélule
Pharmaceutical Form: Capsule*
INN or Proposed INN: Inactivated Lactobacillus LB (Lactobacillus delbrueckii and Lactobacillus fermentum) and fermented culture medium
Sponsors
AXCAN PHARMA SAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant, non nursing women, 18 years of age or above.Women of childbearing potential will need to use a medically acceptable contraceptive regimen (systemic contraceptive, intrauterine/intravaginal method or barrier-method). 2. Subjects must meet the Rome III Diagnostic Questionnaire for IBS 3. Subjects having an IBS Symptom Severity Scale (IBS-SSS) score ranging between 100 and 400 4. Subjects having an average Bristol Stool Form Scale score exceeding two (>2) but less than seven (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Inflammatory Bowel Disease (IBD) 2. Chronic use of systemic steroids (on more than 7 consecutive days) in the month prior to screening 3. Presence of Type 1 or Type 2 diabetes mellitus 4. Suffering from a major psychiatric disorder within the past 2 years prior to screening 5. Diagnosis of autoimmune diseases or disorders (ex: Rheumatoid arthritis, Celiac disease, Multiple sclerosis) 6. Had undergone any invasive abdominal surgery, with the exception of hernia repair or appendectomy or cholecystectomy 7. Presence of current or recent ( within 1 month prior to screening) hematemesis, melena or documented gastrointestinal bleeding or iron-deficiency anemia of clinical signifiance 8. Presence of malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) or any radiation therapy during the previous 5 years prior to screening 9. Use of antibiotics within 30 days prior to screening 10. Use of any experimental drug within 30 days prior to screening 11. Allergy to active substance or any other ingredient in LACTEOL 340mg 12. Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance 13. Diagnosis of exocrine pancreatic insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of LACTEOL 340mg in subjects suffering from diarrhea-predominant Irritable Bowel Syndrome (IBS-D) using the subject global assessment of relief.;Secondary Objective: - To evaluate safety and tolerability of LACTEOL 340mg in this population - To assess treatment compliance;Primary end point(s): Subject global assessment of relief (SGA): subjects will be considered as being responders if they answer "Yes" at least 50% of the time during the 4-week treatment phase. | — |
Countries
France, Germany
Outcome results
None listed