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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT07213856
Eligibility Criteria:
Inclusion Criteria:
* Adults with a previous diagnosis of Parkinson's disease
* On a stable dose of levodopa for at least 3 months
* Diagnosis of Functional Constipation by the Rome IV protocol
Exclusion Criteria:
* Diagnosis of atypical or secondary parkinsonism
* Hoehn and Yahr stage greater than 2
* Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures
* Previous diagnosis of dementia
* Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and/or chronic kidney disease
* History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract
* Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus
* Use of opioids
* Use of probiotics or antibiotics in the past 8 weeks
* Continuous use of laxatives in the past 8 weeks
* Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)
* Individuals receiving enteral or parenteral nutrition
* Individuals under nutritional follow-up in the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07213856
Study Brief:
Protocol Section:
NCT07213856