← Back to all trials
Recruiting
NCT07213856
Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease
Conditions: Parkinsons Disease (PD), Constipation - Functional
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 54
Sponsor: Hospital de Clinicas de Porto Alegre
Location: Hospital de Clínicas de Porto Alegre (HCPA) Porto Alegre Rio Grande do Sul
Summary
The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are:
* Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?
* Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?
Researchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes.
Participants will:
* Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation
* Participate in follow-up sessions with the dietitian for 3 months
* Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality
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
Source: ClinicalTrials.gov (NCT07213856). StuddyBuddy aggregates publicly available trial information.