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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT06566157
Eligibility Criteria:
Inclusion Criteria:
* Aged 18-25 at time of recruitment
* Body Mass Index (18.5 - 29.9 kg) : Healthy - Overweight
* Stress score of 15≤ - ≥25 (DASS)
* Willing and with capacity to give informed consent to participate at time of recruitment
* Speak and comprehend English to a good standard
* In good general health
* Willing to provide stool, urine and blood (8mL) sample during intervention
* Willing to attend 4 visits to Southampton General Hospital Clinical Research Facility over 10-11 weeks
Exclusion Criteria:
* Consuming ≥ 14 units of alcohol/week (6 x 175 mL of wine, 6 pints of 4% beer)
* Learning or behavioural difficulties (assessed on individual basis)
* Planning a pregnancy in the next 6 months, pregnant, lactating or had a recent birth ≥6 months
* Currently smoking or using e-cigarette, vape
* Vulnerable adults (with self reported sever or very severe stress score (DASS)
* Unwilling to suspend existing probiotic / prebiotic supplementation (with additional 4 weeks washout) before starting study.
Medical exclusions:
* Actively involved in therapy or psychiatric intervention of a diagnosed mental health condition
* Prescribed psychotropic medication (Antidepressants, Monoamine Oxidase Inhibitors (MAOI's), Antipsychotics, sleeping pills, mood stabilisers etc)
* Allergic to milk, soy, corn, penicillin or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPS)
* Currently prescribed laxatives, enemas, anti-coagulants or painkillers
* Existing medical condition: cancer, hepatobiliary surgery, diabetes or diagnosed gastrointestinal diseases (irritable bowel disease, ulcerative colitis)
* Involved in a recent pharmacology/psychological intervention, last 6 months
* Recent antibiotic prescription, last 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT06566157
Study Brief:
Protocol Section:
NCT06566157