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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT01927666
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 or over
* Smokers and non-smokers
* Those that live within 40 miles, and 2 hours travelling time, of Norwich
Exclusion Criteria:
* Women who are or have been pregnant within the last 12 months or breast feeding.
* Those currently suffering from or have ever suffered from any gastrointestinal disease, gastrointestinal disorders and/or surgery including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic) or study intervention/procedure is contraindicated.
* Have been diagnosed with any long-term medical condition that may affect the study outcome (e.g. diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia). These will be assessed on an individual basis.
* On medication that may affect the study outcome.
* Those that have used antibiotics within the previous one month or on long-term antibiotic therapy.
* Those regularly taking laxatives (once a month or more)
* Those intermittently using pre \&/or pro biotics unless willing to abstain for 1 month prior and during study period. (If used regularly (3+ times a week, and for more than one month) and will continue throughout study period then do not exclude).
* Those taking dietary supplements or herbal remedies which may affect the study outcome -unless the participant is willing to discontinue taking them for 1 month prior to starting study. Please note that some supplements may not affect the study and this will be assessed on an individual basis
* Regular/ recent (within 3 months) use of colonic irrigation or other bowel cleansing techniques.
* Parallel participation in another research project which involves dietary intervention and/or sampling of blood
* Any person related to or living with any member of the study team
* Participation in another research project which involves blood sampling within the last four months unless total blood from both studies does not exceed 470mL
* are unwilling to provide GPs contact details
* are unable to provide written informed consent
* are not suitable to take part in this study because of your screening results
* have donated or intend to donate blood within 16 weeks of the first and last study samples
* Those with a body mass index (BMI, kg/m2) \<20
* Those who are unable to swallow capsules
* Those who do not have access to a freezer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01927666
Study Brief:
Protocol Section:
NCT01927666