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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01084434
Eligibility Criteria:
Inclusion Criteria:
* Signed consent form
* Age 40-65 years
* Body mass index 18.5-30 inclusive
* Good general health as determined by medical questionnaires
* Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine
Exclusion Criteria:
* Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study
* History of drug misuse, including alcohol
* Allergy to the vaccine
* Asplenia and other acquired or congenital immunodeficiency
* Severe allergy such as asthma, hay-fever, dermatitis or being treated on these
* History of severe abnormal drug reaction
* Any autoimmune disease
* Diabetic (type 1 or type2)
* Food allergy manifested by gastrointestinal, skin, respiratory , neurological, anaphylaxis symptoms
* Lactose intolerance showed by clinical symptoms such as nausea, cramping, bloating, diarrhea and flatulence after consuming lactose containing dairy products (milk, yoghurt, butter, cheese, ice-cream, sour cream) or lactose non-dairy products ( whey, milk solids, modified milk ingredients)
* Participation in experimental drug trial within four weeks prior to study
* Participation in prebiotics or laxative trial within the previous three months
* Use of antibiotics within the previous six months
* Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint
* Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study
* Use of prescribed medication
* Regular use of aspirin or other anti-inflammatory drugs
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT01084434
Study Brief:
Protocol Section:
NCT01084434