Treatment of Diarrhea-predominant Irritable Bowel Syndrome with LACTEOL 340 mg : a pilot study evaluating safety and efficacy

Phase 1

• Conditions: Diarrhea-predominant Irritable Bowel Syndrome; MedDRA version: 12.1Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndrome

• Registration Number: EUCTR2009-017874-20-FR
• Lead Sponsor: AXCAN PHARMA SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-02
• Study Completion: 2011-09-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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 (<7)
5. Subject is on a stable diet (no drastic lifestyle changes in the quantity and nature of food) for the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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.