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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT01127828
Eligibility Criteria:
Inclusion Criteria:
Signed consent to participate age 18-70 years IBS according to Rome II criteria
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Exclusion Criteria:
1. Participation in a clinical study one month prior to screening visit and throughout the study.
2. Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
3. Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
4. Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
5. Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
6. Severe psychiatric disease as judged by the investigator.
7. Previous history of drug or alcohol abuse six months prior to screening.
8. Intolerance or allergy against milk products or gluten.
9. Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
10. Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
11. Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
12. Pregnant or lactating or wish to become pregnant during the period of the study.
13. Lack of suitability for participation in the study for any reason as judged by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01127828
Study Brief:
Protocol Section:
NCT01127828