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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03917693
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged between 18 and 50
* Non-smokers (e-cigarette/vape users are able to participate)
* Those with a body mass index (BMI) between 19.5 and 30 kg/m\^2
* Those that live within a 40-mile radius of Norwich
Exclusion Criteria:
* results of our screening test indicate the participant is not suitable to take part in this study
* are pregnant, have been pregnant in the last year or are lactating and/or breast feeding
* are currently suffering from, or have ever suffered from, any diagnosed gastrointestinal disease, gastrointestinal disorders including regular diarrhoea and constipation (excluding hiatus hernia unless symptomatic), and/or have undergone gastrointestinal surgery, or the study intervention/procedure is contraindicated
* have been diagnosed with any long-term medical condition that may affect the study outcome (e.g. cancer, diabetes, haemophilia, cardiovascular disease, glaucoma, anaemia). These will be assessed on an individual basis
* have been diagnosed with any long-term medical condition requiring medication that may affect the study outcome
* regularly taking over the counter medications for digestive/gastrointestinal conditions
* are on long-term antibiotic therapy. Participant may be able to take part if 4 weeks has passed from the end of a course of antibiotics (this will be assessed on an individual basis)
* regularly take laxatives (once a month or more)
* take certain dietary supplements or herbal remedies and are unwilling to stop taking them for one month prior to and during study period. This will be assessed on an individual basis
* take pre- or pro-biotic drinks \&/or yoghurts on an occasional basis, unless willing to abstain for one month prior to and during the study period. (if participant regularly takes pre-\&/or pro biotics (3+ times a week, and for more than one month) and will continue throughout the study then participant will not be excluded)
* are on or plan to start a diet programme that may affect the study outcome (e.g. 5:2 fasting diet) unless willing to abstain for 1 month prior to and during study period. This will be assessed on an individual basis
* recently returned to the United Kingdom (UK) following a period abroad, and who have suffered gastric symptoms during the period abroad or on return to the UK. These will be assessed on an individual basis
* regular/recent (within 3 months) use of colonic irrigation or other bowel cleansing techniques
* are involved in another research project that includes dietary intervention or involving blood sampling
* record blood in participant's stools or have two or more episodes of constipation or diarrhoea (type 1, 2, or 7 stools) during the study
* are unwilling to provide their General Practioner's (GP's) contact details
* are unable to provide written informed consent.
* regularly consume more than 15 units (women) or 22 units (men) of alcohol a week
* Regularly taking iron supplements
* Those unable to swallow capsules
* Those with abnormal blood pressure measurements (160/100 will be regarded as an exclusion value)
* Are related to someone in the study (e.g. spouse, partner, immediate family member)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03917693
Study Brief:
Protocol Section:
NCT03917693