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 @ 2:20 PM
Ignite Modification Date:
2025-12-24 @ 2:20 PM
NCT ID:
NCT04199195
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged at least 60 years.
* Must be able to provide informed consent.
* Must be able to complete the Cognitive Tests/Questionnaires, Health Questionnaires by themselves and be familiar with using an ipad/tablet.
Exclusion Criteria:
* Currently taking part in an interventional study.
* Living with or related to any member of the research team.
* Have a diagnosis of Dementia, Parkinson's Disease, Alzheimer's Disease, Creutzfeldt-Jakob disease (CJD), Picks Disease.
* Bipolar Disorder.
* Obsessive Compulsive Disorder.
* Untreated current clinical depression.
* Have irreversible brain injury.
* Have had a stroke.
* Have epilepsy.
* Take more than a daily dose of probiotics.
* Have a long-standing gastrointestinal or liver function abnormality requiring on- going medical management or medication.
* History of cancer within the last 5 years except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
* Unstable dietary history as defined by major changes in diet during the previous month, where a major food group in the diet has been stopped or significantly increased, for example become vegetarian, vegan or stopped eating red meat.
* History of alcohol, drug or substance abuse. History of Hepatitis B or Hepatitis C.
* Major surgery of the gastrointestinal tract, apart from gall bladder or appendix removal, in the past five years.
* Any major bowel resection at any time.
* History of Ulcerative Colitis, Crohn's Disease or Diverticulitis.
* Persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhoea of unknown cause, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
* Constipation.
* Regular use of laxatives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04199195
Study Brief:
Protocol Section:
NCT04199195