Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT01252550
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Age: between 18 and 65 years old at baseline visit
* IBS according to the Rome III criteria
* Ability to understand and willingness to comply to the study procedures
Exclusion Criteria:
* Participation in another clinical study 1 month prior to screening visit and throughout the study
* Abnormal results on the screening laboratory tests clinically relevant for study participation
* Other gastrointestinal disease(s) explaining the patient's symptoms, as judged by the investigator
* Other severe disease(s) such as malignancy, severe heart disease, kidney disease or neurological disease
* Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, weight loss or fever
* Severe psychiatric disease
* Previous history of drug or alcohol abuse 6 months prior to screening
* Intolerance or allergy against milk products or gluten
* Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study
* Consumption of antibiotics 1 month prior to screening and throughout the study
* Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study
* Pregnant or lactating or wish to become pregnant during the period of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01252550
Study Brief:
Protocol Section:
NCT01252550