Irritable Bowel Syndrome
Conditions
Interventions
Capsules with Lactobacillus plantarum 299v or placebo
Sponsors
Probi A
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Willing and able to provide informed consent - Age *18 and * 70 years at Visit 1 - IBS according to the Rome III criteria - A score on abdominal pain NRS * 3 and * 6 at least two days a week measured the weeks before Visit 2 (baseline) - IBS-SSS * 75 and * 300 at Visit 2 (baseline) - Ability and willingness to understand and comply with the study procedures
Exclusion criteria
Exclusion criteria: - Known intolerance or allergy to milk products (protein or lactose) or gluten - History of alcohol or substance abuse six months prior to screening - Known Hepatitis B or C Human Immunodeficiency Virus (HIV) 1 or 2 - Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study - Abnormal results of the screening laboratory tests clinicallly relevant for study participation, as judged by the Investigator - Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator - Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator - Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator - Severe psychiatric disease as judged by the Investigator - Lack of suitability for participation in the study for any reason as judged by the Investigator - Use of other probiotic products (according Sponsor's list) from Visit 1 and throughout the study - Consumption of antibiotic drugs 1 month prior to screening and throughout the study - Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary object is to determine the effect of Lactobacillus plantarum 299v on abdominal pain over 4 weeks of consumption in comparison to placebo in IBS out-patients determined with pain nummeric rating scale (NRS). The primary efficacy endpoint ischange from baseline in abdominal pain NRS after 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The effect of Lactobacillus plantarum 299v on the total scores of IBS severity scoring system (IBS-SSS) over 4 weeks consumption with placebo in IBS out-patients - The effect of Lactobacillus plantarum 299v on flatulence over 4 weeks consumption in comparison with placebo in IBS out-patients determined with a flatulence scale - The effects of Lactobacillus plantarum 299v on bloating over 4 weeks consumption in comparison with placebo in IBS out-patients determined with IBS-SSS - The effects of Lactobacillus plantarum 299v on stool form and frequency according to the Bristol stool form (BSF) over 4 weeks consumption in comparison with placebo in IBS out-patients - The effects of Lactobacillus plantarum 299v on faecal microflora after 4 weeks consumption in comparisons with placebo - The effects of Lactobacillus plantarum 299v on gastrointestinal (GI) wellbeing/comfort after 4 weeks consumption in comparison with placebo -The effects of Lactobacillus plantarum 299v on global efficacy after 4 weeks consumption in comparison with placebo - The frequency of Adverse Events collected during the study | — |
Countries
Netherlands
Outcome results
None listed