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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04140760
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of idiopathic Parkinson's disease based on UK PD Society Brain Bank criteria.
* Capacity to consent and complete questionnaires.
* Absence of gut/intestinal disorders that would prevent use of a probiotic and/or cause diarrhoea.
* Absence of coincidental neurological condition.
* Using l-dopa plus or minus a dopaminergic agonist.
* Age over 18 and under 80
Exclusion Criteria:
* Unable to consent.
* Use of systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral).
* Use of commercial probiotics: includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
* Presence of acute viral/bacterial infection disease at the time of sampling (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
* Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
* History of active uncontrolled gastrointestinal disorders or diseases including: inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis.
* Presence of persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated).
* Presence of incidental neurological illness.
* Experience of any type of cancer or adenoma less than 5 years previously.
* Age over 80
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04140760
Study Brief:
Protocol Section:
NCT04140760