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 @ 3:39 AM
Ignite Modification Date:
2025-12-25 @ 3:39 AM
NCT ID:
NCT05051202
Eligibility Criteria:
Inclusion Criteria:
* Give written informed consent;
* Be between 18 and 60 years of age inclusive;
* Have a body mass index \<30 Kg/m2;
* Be in general good health, as determined by the investigator;
* Have a habitual dietary intake of ≥13g fibre/day;
* Self-reported consumption of a generally 'healthy diet'.
Exclusion Criteria:
* Females who are pregnant, lactating or wish to become pregnant during the study;
* Participant has self-reported low-energy diet or other extreme dietary habits;
* Have experienced recurrent loose stool within the past 4 weeks;
* Recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks;
* Have taken a medication or dietary supplement that may influence GI activity within the 2-weeks prior to screening;
* Have a history of abdominal surgery (excluding appendectomy);
* Have taken anaesthesia within the past 4 weeks;
* Have a known or suspected food allergy or intolerance to any of the investigational product ingredients;
* Have taken antibiotics within the past 12-weeks;
* Have a recent history of drug and/or alcohol abuse at the time of enrolment;
* Are a smoker (defined as \>5 cigarettes/week);
* Have made any major dietary change in the past 3 months;
* Have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
* Have an active gastrointestinal disorder or previous gastrointestinal surgery;
* Have irritable bowel syndrome, diagnosed or undiagnosed and treated with chronic medications;
* Have a gastrointestinal disease i.e., chronic diarrhoea, Crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers, or with a history of such diseases;
* Have a metabolic or endocrine disorder such as diabetes, thyroidism, or other metabolic disorder;
* Have a severe chronic disease i.e. cancer, renal failure, hepatitis, HIV, cirrhosis etc., or with a history of such diseases;
* Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a systemic steroid for \>30 days, or chemotherapy or radiotherapy within the last year);
* Have a personal history of anorexia nervosa, bulimia, or significant eating disorders;
* Experiences alarm features such as unintentional weight loss, rectal bleeding, recent change in bowel habit (\<3 months) or abdominal pain;
* Participants who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
* Participant is currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05051202
Study Brief:
Protocol Section:
NCT05051202