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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT07127120
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Parkinson's Disease by a Neurologist
* Be able to give written informed consent
* Be aged between 60-75 years
* Participants are on a stable drug regimen
* Willing to consume the study product daily for the duration of the study
* Willing to abstain from pre and probiotics for 2 weeks prior to the study and throughout the 28 days of the intervention
Exclusion Criteria:
* Participants has acute or chronic gastrointestinal disease (coeliac disease, diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers) except for hiatal hernia, gastroesophageal reflux disease, haemorrhoids.
* Participants who have consumed probiotic supplements and prebiotic supplements within 2 weeks prior to Visit 1.
* Participant suffering from severe renal disease (creatinine greater than 2.5 times normal)
* Participants with markedly abnormal liver function (alt/ast greater than 2.5 times normal)
* Plan to have a major change in dietary habits during the study.
* Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
* Individuals 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 study.
* Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
* Consumption of non-standard diet (vegetarian, vegan, gluten free, or paleo)
* Elevated bilirubin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT07127120
Study Brief:
Protocol Section:
NCT07127120