Irritable Bowel Syndrome
Conditions
Brief summary
To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.
Interventions
DIETARY_SUPPLEMENTProbiotics
DIETARY_SUPPLEMENTControl placebo
Sponsors
Probi AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
* 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 or 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 clinically 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 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 | Description |
|---|---|---|
| Abdominal pain | 28 days | 0-10 numeric rating scale (NRS) |
Countries
Netherlands
Outcome results
None listed